Table 1. The comparative study as per recent edition of IP ^23,24,25,26 BP ^27,28 and USP²⁹ for Quality control parameters and specifications of tablets are as follows.

Tablets
Sr. No.	Tests	I.P 2022	B.P 2025	U.S.P 2024 Issue 3
1	Subdivision of Tablets	The tablets comply with the test if NMT 1 individual mass is outside the limits of 85% -115% of average mass. The tablet fails to comply with the test if more than 1 individual mass is outside these limits or if 1 individual mass is outside the limits of 75% -125% of the average mass.	The tablets comply with the test if each individual content is between 85% -115% of average mass. The tablet fails to comply with the test if more than 1 individual mass is outside these limits or if 1 individual mass is outside the limits of 75% -125% of the average mass.	An acceptable tablet breaks into the designed number of segments, and each split portion has NLT 75% and NMT 125% of the expected weight of the split tablet portion. [NOTE—Set aside split tablet portions derived from acceptable tablets for subsequent testing for dissolution or disintegration.] Acceptance criteria: NLT 28 of the 30 tablets are acceptable.
2	Uniformity of Container Content
	Content of Packaged Dosage Form	Avg. no. of contents in the 10 containers is NLT the L.A. and Number in any single container is, NLT 98% of L.A. If requirement is not met, determine no. of content in 20 additional containers. The avg. number in 30 containers is not less than L.A. and the number in not more than one of the 30 containers is less than 98% of L.A. (Page No. 367 Vol. I)	N.A. [Not Applicable]	N.A.
3	Content of active Ingredient	90 – 110 %	90 – 110 %	Covered under Uniformity of dosage units

Sr. No.	Tests	I.P 2022	B.P 2025	U.S.P 2024 Issue 3
4	Uniformity of Dosage units	1. For Uncoated and Film coated Tablets with dose and ratio of active substance ≥ 25 mg and ≥ 25 % carry out Mass variation otherwise carry out Content uniformity test. (i.e. with < 25 mg or < 25%) 2. For other coated tablets carry out Content uniformity in both the conditions.	1. For Uncoated and Film coated Tablets with dose and ratio of active substance ≥ 25 mg and ≥ 25 % carry out Mass variation otherwise carry out Content uniformity test. (i.e. with < 25 mg or < 25%) 2. For other coated tablets carry out Content uniformity in both the conditions.	1. For Uncoated and Film coated Tablets with dose and ratio of drug substance ≥ 25 mg and ≥ 25 % carry out Weight variation otherwise carry out Content uniformity test. (i.e. with < 25 mg or < 25 %) 2. For other coated tablets carry out content uniformity in both the conditions.
5	Uniformity of Weight	80 mg or less - 10 %	Not more than 80 mg - 10 %	N.A.
		More than 80 mg but less than 250 mg - 7.5 %	More than 80 mg and less than 250 mg - 7.5 %
		250 mg or more - 5 %	250 mg or more - 5 %
6	Content Uniformity	Uniformity of Dosage unit by Content uniformity The requirements are met if the acceptance value of the first 10 dosage units is less than or equal to L1%. If the acceptance value is > L1%, test the next 20 units, and calculate the acceptance value. The requirements are met if the final acceptance value of the 30 dosage units is ≤ L1%, and no individual content of any dosage unit is less than [1 − (0.01) (L2)]M nor more than [1 + (0.01) (L2)]M as specified in the Calculation of Acceptance Value under Content Uniformity or under Weight Variation. Unless otherwise specified, L1 is 15.0 and L2 is 25.0. (Reference IP:2.5.4 (i)	Uniformity of dosage unit by content Uniformity The requirements are met if the acceptance value of the first 10 dosage units is less than or equal to L1 per cent. If the acceptance value is greater than L1 per cent, test the next 20 dosage units and calculate the acceptance value. The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to L1 per cent and no individual content of the dosage unit is less than (1 -L2 × 0.01) M or more than (1 + L2 × 0.01) M in calculation of acceptance value under content uniformity or under mass variation. Unless otherwise specified, L1 is 15.0 and L2 is 25.0.	Uniformity of Dosage unit by Content Uniformity The requirements are met if the acceptance value of the first 10 dosage units is less than or equal to L1%. If the acceptance value is > L1%, test the next 20 units, and calculate the acceptance value. The requirements are met if the final acceptance value of the 30 dosage units is ≤ L1%, and no individual content of any dosage unit is less than [1 − (0.01) (L2)]M not more than [1 + (0.01) (L2)]M as specified in the Calculation of Acceptance Value under Content Uniformity or under Weight Variation. Unless otherwise specified, L1 is 15.0 and L2 is 25.0.
		Criteria: For tablet API= 10 mg or < 10 % w/w - CU is applicable for uncoated, film and another coated tablet For tablet API= more than 10 mg or more than 10 % w/w – CU is not applicable for Uncoated and film coated tablet but applicable for other than film coated tablets (if justified and authorized) Complies- If each individual content is 85-115 % of Avg content. Fail to comply - If more than one individual content is outside the limit 85-115 % of Avg content and 1 individual content is outside the limit of 75 - 125 % of Avg. content (Page No. 1343 Vol. II)	Criteria: Unless otherwise prescribed tablets with API = less than 2 mg or less than 2 % of the total mass comply with the test A for uniformity of content of single dose preparations. If the preparation has more than 1 active substance, the requirement applies only to those substances that correspond to the above conditions. Test A Complies - If each individual content is 85-115 % of Avg content. Fail to comply – If 1 individual content is outside the limit of 75 - 125 % of Avg. content If one individual content is outside the limits of 85 per cent to 115 per cent but within the limits of 75 per cent to 125 per cent, determine the individual contents of another 20 dosage units taken at random. The preparation complies with the test if not more than one of the individual contents of the 30 units is outside 85 per cent to 115 per cent of the average content and none is outside the limits of 75 percent to 125 per cent of the average content.	Covered under Uniformity of dosage units by content uniformity

Sr. No.	Tests	I.P 2022	B.P 2025	U.S.P 2024 Issue 3
7	Disintegration Time (N.A. for Chewable Tablets)	Note: Use Apparatus A for Tablets and Capsules that are NMT 18 mm long. For Larger tablets and Capsules use Apparatus B	Note: Use Apparatus A for Tablets and Capsules that are not greater than 18 mm long. For larger tablets and capsules use apparatus B	As per USP for Chewable Tablets: Apply the Procedure and Criteria for Uncoated or Plain-Coated Tablets.
	Uncoated Tablets	NMT 15 minutes	NMT 15 minutes	As per individual monograph
	Film Coated Tablets	NMT 30 minutes	NMT 30 minutes	Plain Coated Tablets: As per individual monograph
	Other than Film Coated Tablets	NMT 60 minutes	NMT 60 minutes	N.A.
		Use water as liquid. If any of tablets not disintegrated, repeat test on 6 tabs, replacing water with 0.1 M HCl.	In Water at 37 ± 2⁰C	N.A.
	Dispersible Tablets	NMT 3 minutes at 24 to 26°C (Mouth dissolving)	NMT 3 minutes, at 15 to 25^°C. (Or dispersible Tablets)	Same as Uncoated or Plain-Coated Tablet (Orally disintegrating)
	Uniformity of Dispersion/ Fineness of Dispersion	Two Tablets + 100 ml Water – Smooth dispersion formed.
	Uniformity of Dispersion/ Fineness of Dispersion	A smooth dispersion passes through a sieve screen with Nominal Mesh Aperture of 710 µm.	A smooth dispersion passes through a sieve screen with Nominal Mesh Aperture of 710 µm.	N.A.
	Enteric Coated / Gastro- Resistant / Delayed Release Tablets (Omit the use of disk)	No signs of disintegration in 0.1 M HCl in 120 minutes (without disk) and disintegration in Phosphate Buffer pH 6.8 in further 60 min (add disk).	No signs of disintegration in 0.1 M HCl in 120 minutes and disintegration in Phosphate Buffer pH 6.8 in further 60 min.	No signs of disintegration in SGF in 60 minutes and disintegration in SIF for time as per monograph
	Buccal Tablets	N.A.	N.A.	Same as Uncoated or Plain-Coated Tablet
	Soluble Tablets	NMT 3 minutes, at 15 to 25°C.	NMT 3 minutes, at 15 to 25°C.	NA
	Effervescent Tablets	NMT 5 minutes.	NMT 5 minutes.	5 min or as specified in the individual monograph
	Sublingual Tablets	NMT 3 minutes, at 15 to 25°C.	N.A.	Same as Uncoated or Plain-Coated Tablet
8	Friability Test	For tablets with an avg. wt. ≤ 0.65 g, take a sample of whole tablets corresponding to about 6.5 g. For tablets with an avg. wt. > 0.65 g, take a sample of 10 whole tablets. Carry out 100 Rotations,	For tablets with a unit mass ≤ 650 mg, take a sample of whole tablets corresponding to about 6.5 g. For tablets with a unit mass ≥ 650 mg, take a sample of 10 whole tablets. Carry out 100 Rotations,	For tablets with an avg. wt. ≤ 0.65 g, take a sample of whole tablets corresponding to about 6.5 g. For tablets with an avg. wt. > 0.65 g, take a sample of 10 whole tablets. Carry out 100 Rotations,
		% Loss: NMT 1 % if fails repeat the test for two times, (From single test or from mean of three tests maximum loss of weight NMT 1%)	% Loss: NMT 1 % if fails repeat the test for two times, (From single test or from mean of three tests maximum loss of weight NMT 1%)	% Loss: NMT 1 % if fails repeat the test for two times, (From single test or from mean of three tests maximum loss of weight NMT 1%) ,
		Avg. of 3 tests = NMT 1 %	Avg. of 3 tests = NMT 1 %	Avg. of 3 tests = NMT 1 %
9	Residual Solvents
	Class 1 Solvents (Associated with unacceptable toxicity)	Acceptance criteria is as per IP/ICH Q3C class 1 solvent	Acceptance criteria is as per BP/ ICH Q3C class 1 solvent	Acceptance criteria is as per USP/ ICH Q3C class 1 solvent
	Class 2 Solvents (Associated with less severe toxicity)	Acceptance criteria is as per IP/ICH Q3C class 2 solvent	Acceptance criteria is as per BP/ICH Q3C class 2 solvent	Acceptance criteria is as per USP/ ICH Q3C class 2 solvent
	Class 3 Solvents (Less toxic and of lower risk to human health)	Acceptance criteria is as per IP/ICH Q3C class 3 solvent	Acceptance criteria is as per BP/ICH Q3C class 3 solvent	Acceptance criteria is as per USP/ ICH Q3C class 3 solvent

Sr. No	Test	I.P 2022	B.P 2025	U.S.P 2024 Issue 3
10	Dissolution
	Conventional Release Dosage Forms (as per IP, BP) / Immediate-Release Dosage Forms (as per USP) (For IR Products)	As per individual monograph or Each unit is not less than Q* + 5 %**. Acceptance Criteria: S1+S2+S3	As per individual monograph or Each unit is not less than Q* + 5 %**. Acceptance Criteria: S1+S2+S3	As per individual monograph or Each unit is not less than Q* + 5 %*. For pooled sample: avg. amount dissolved is not less than Q + 10 %**. Time: 30 - 60 min. / NMT 60 min. Acceptance Criteria: S1+S2+S3
	Prolonged - release dosage forms (as per IP, BP) / Extended Release Dosage Forms (as per USP), (For SR Products)	As per individual monograph or 1^stTime Point: 20 - 30 % of active dissolved 2^nd Time Point: 40 - 60 % of active dissolved 3^rd Time Point: More than 80 % of active dissolved. Acceptance criteria: L1+L2+L3	As per individual monograph or No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time. B52 Acceptance criteria: L1+L2+L3	As per individual monograph or No individual value lies outside each of the stated ranges and No individual value is less than the stated amount at final test time. Acceptance criteria: L1+L2+L3
	Delayed - release Dosage Forms (as per IP/BP/USP) Modified - release dosage forms [Gastro resistance tablets] (as per IP) (For Enteric Coated Products)	As per IP Modified-release tablets includes Gastro-resistant tablets and Prolonged -release tablets.	As per BP Modified-release tablets includes Prolonged -release tablets, delayed- release tablets and pulsatile-release tablets.
		As per individual monograph or for Acid Stage: No individual value exceeds 10 % dissolved. Acceptance Criteria: A1+A2+A3 Buffer Stage: No unit is less than Q* + 5 %. Acceptance Criteria: B1+B2+B3	As per individual monograph or for Acid Stage: No individual value exceeds 10 % dissolved. Acceptance Criteria: A1+A2+A3 Buffer Stage: No unit is less than Q* + 5 %. Acceptance Criteria: B1+B2+B3	As per individual monograph OR for Acid Stage: No individual value exceeds 10 % dissolved. Acceptance Criteria: A1+A2+A3 Buffer Stage: No unit is less than Q*+5 %. Acceptance Criteria: B1+B2+B3

*D, Q: is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content. **: Percentages of the labeled content. ***D/Q = 75 % dissolved unless otherwise specified.

Sr. No	Test	I.P 2022	B.P 2025	U.S.P 2024 Issue 3
11	Microbial Limit Test
	Total Aerobic Viable Count	1000 per g	1000 per g	1000 per g
	Total Fungal Count	100 per g	100 per g	100 per g
	Escherichia coli	Should be absent per g	Should be absent per g	Should be absent per g
12	Impurities / Related substances
	a) For Drug substances	As per Table No. A	As per individual monograph (if not given then Inhouse Test limits should be applied: Substances for Pharmaceutical use. Ph Eur monograph)	As per individual monograph Ordinary Impurities: NMT 2 % unless otherwise specified in the individual monograph.
	a) For Drug substances	As per Table No. A		Ordinary Impurity monograph
	b) For Drug products	As per Table No. B	As per individual monograph (if not given then Inhouse Test limits should be applied: Substances for Pharmaceutical use. Ph Eur monograph)	As per individual monograph as per ICH/US FDA/ USP monograph submission guidelines. Ordinary Impurities: NMT 2 % unless otherwise specified in the individual monograph.
	b) For Drug products	As per Table No. B

Table No. A: Reporting, identification and qualification of organic impurities in drug substances

Use	Maximum daily dose	Reporting threshold	Identification threshold	Qualification threshold
Human or Human and veterinary use	≤ 2 g	0.05%	0.10% (1.0 mg)^$	0.15 % (1.0 mg)^$
Human or Human and veterinary use	> 2 g	0.03%	0.05%	0.05%
veterinary use only	N.A.	0.1%^@#	0.2%^#	0.5%^#

$: Total daily intake (TDI; in parentheses) applies if it is lower than the calculated value.

@: Higher reporting thresholds should be scientifically justified.

#: Lower threshold can be appropriate if the impurity is unusually toxic

Table No. B: Reporting, identification and qualification of organic impurities or degradation products in drug products

Use	Maximum daily dose	Reporting threshold	Identification threshold	Qualification threshold
Human use	< 1 mg	0.10%	1.0 % (5 µg)^$	1.0 % (50 µg)^$
	≥ 1 to < 10 mg	0.10%	0.5% (20 µg)^$	1.0 % (50 µg)^$
	10 mg	0.10%	0.5% (20 µg)^$	0.5% (200 µg)^$
	> 10 - 100 mg	0.10%	0.2% (2 mg)^$	0.5% (200 µg)^$
	> 100 mg - 1 g	0.10%	0.2% (2 mg)^$	0.2% (3 mg)^$
	> 1 - 2 g	0.05%	0.2% (2 mg)^$	0.2% (3 mg)^$
	> 2 g	0.05%	0.10%	0.15%
veterinary use only	N.A.	0.3 %^#	1.0 %^#	1.0 %^#

$: Whichever is lower, calculated value or TDI (in parentheses).

#: Higher threshold should be scientifically justified.

Table 2. The comparative study as per recent edition of IP^23,24,25,26, BP^27,28 and USP²⁹ for Quality control parameters and specifications of capsules are as follows.

	Capsule
Sr. No	Test	I.P 2022	B.P 2025	U.S.P 2024 Issue 3
1	Content of Packaged Dosage Form	Avg. no. of contents in the 10 containers is NLT the L.A. and No. in any single container is NLT 98 %.	N.A.	N.A.
2	Content of active Ingredient	90 – 110 %	90 – 110 %	Covered under Uniformity of dosage units
3	Content Uniformity NA to capsules containing multivitamins and trace elements.	API = 10 mg or less than 10 mg or less than 10 %w/w of active ingredient. Complies - if NMT 1 individual content is outside 85 - 115 % and none is outside 75 - 125 % of avg. content.	Unless otherwise prescribed capsules with API = less than 2 mg or less than 2 % of the fill mass comply with the test B for uniformity of content of single dose preparations. Covered under Uniformity of content and Uniformity of dosage units [2.9.5, 2.9.6, 2.9.40]	Covered under Uniformity of dosage units
4	Uniformity of Weight	Avg. wt. of capsule content - % deviation		N.A.
		Less than 300 mg - 10 %	Less than 300 mg - 10 %
		300 mg or More - 7.5 %	300 mg or More - 7.5 %
5	Uniformity of Dosage units	1. For Hard gelatin capsules and soft gelatin capsules containing solutions with dose and ratio of active substance ≥ 25 mg and ≥ 25 % carry out weight variation otherwise carry out Content uniformity test. (i.e. with < 25 mg or < 25 %) 2. For Hard gelatin capsules with dose and ratio of active substance < 25 mg or < 25 % carry out content uniformity test, For Soft gelatin capsules containing Susp./Emul./Gel carry out Content uniformity in both the conditions and For Soft gelatin capsules containing solutions carry out weight variation test in both the conditions..	1. For Hard gelatin capsules and soft gelatin capsules containing solution with dose and ratio of active substance ≥ 25 mg and ≥ 25 % carry out Mass variation otherwise carry out Content uniformity test. (i.e. with < 25 mg or < 25 %) 2. For Hard gelatin capsules with dose and ratio of active substance < 25 mg or < 25 % carry out content uniformity test, for Soft gelatin capsules containing Susp. /Emul./Gel carry out Content uniformity in both the conditions and For Soft gelatin capsules containing solutions carry out Mass variation test in both the conditions.	1. For Hard gelatin capsules with dose and ratio of drug substance ≥ 25 mg and ≥ 25 % carry out Weight variation otherwise carry out Content uniformity test. (i.e. with < 25 mg or < 25 %) 2. For Soft gelatin capsules containing Susp. /Emul. /Gel carry out Content uniformity in both the conditions and For Soft gelatin capsules containing solutions carry out Weight variation test in both the conditions.
6	Disintegration Time
	Hard Gelatin Capsules	NMT 30 minutes, in Water	NMT 30 minutes, in Water/0.1 M HCl/ AGJ	As per individual monograph
	Soft Gelatin Capsules	NMT 30 minutes. in water, replaced with 0.1M HCl or AGJ in repeat test. *AGJ: Artificial Gastric Juice	NMT 30 minutes, in Water/0.1 M HCl/ AGJ *AGJ: Artificial Gastric Juice	As per Individual monograph
	Gastro- Resistant / Delayed Release / Enteric Capsules	No signs of disintegration in 0.1 M HCl in 120 minutes and disintegration in Mixed Phosphate Buffer pH 6.8 in further 60 min. When justified and authorized, a buffer solution of pH 6.8 with added pancreas powder (for example, 0.35 g of pancreas powder R per 100 mL of buffer solution) may be used.	No signs of disintegration in 0.1 M HCl in 120 minutes and disintegration in Phosphate Buffer pH 6.8 in further 60 min. When justified and authorized, a buffer solution of pH 6.8 with added pancreas powder (for example, 0.35 g of pancreas powder R per 100 mL of buffer solution) may be used.	Acid stage- after 1 h No dosage unit shows evidence of disintegration, cracking, or softening. Buffer stage- As specified in the individual monograph when justified and authorized, a buffer solution of pH 6.8 with added pancreas powder (for example, 0.35 g of pancreas powder R per 100 mL of buffer solution) may be used.

Sr. No.	Tests	I.P 2022	B.P 2025	U.S. P 2024 Issue 3
	Hard Cellulose Capsule	NMT 30 minutes, in Water	N.A.
7	Dissolution
	Conventional Release Dosage Forms (as per IP, BP) / Immediate-Release Dosage Forms (as per USP) (For IR Products)	As per individual monograph or Each unit is not less than Q* + 5 %**. Acceptance Criteria: S1+S2+S3	As per individual monograph or Each unit is not less than Q* + 5 %**. Acceptance Criteria: S1+S2+S3	As per individual monograph or Each unit is not less than Q* + 5 %*. For pooled sample: avg. amount dissolved is not less than Q + 10 %**. Acceptance Criteria: S1+S2+S3
	Prolonged - release dosage forms (as per IP, BP) / Extended Release Dosage Forms (as per USP), (For SR Products)	As per individual monograph or 1^stTime Point: 20 - 30 % of active dissolved 2^nd Time Point: 45 - 55 % of active dissolved 3^rd Time Point: More than 80 % of active dissolved. Acceptance criteria: L1+L2+L3	As per individual monograph or No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time. Acceptance criteria: L1+L2+L3	As per individual monograph or No individual value lies outside each of the stated ranges and No individual value is less than the stated amount at final test time. Acceptance criteria: L1+L2+L3
	Delayed - release Dosage Forms (as per BP/ USP) Modified - release dosage forms (as per IP) (For Enteric Coated Products)	As per individual monograph OR for Acid Stage: No individual value exceeds 10 % dissolved. Acceptance Criteria: A1+A2+A3 Buffer Stage: No unit is less than Q* + 5 %. Acceptance Criteria: B1+B2+B3	As per individual monograph OR for Acid Stage: No individual value exceeds 10 % dissolved. Acceptance Criteria: A1+A2+A3 Buffer Stage: No unit is less than Q* + 5 %. Acceptance Criteria: B1+B2+B3	As per individual monograph OR for Acid Stage: No individual value exceeds 10 % dissolved. Acceptance Criteria: A1+A2+A3 Buffer Stage: No unit is less than Q*+5 %. Acceptance Criteria: B1+B2+B3

*D, Q: is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labeled content. **: Percentages of the labeled content.

***D/Q = 75 % dissolved unless otherwise specified.

Sr. No.	Tests	I.P 2022	B.P 2025	U.S. P 2024 Issue 3
8	Residual Solvents
	Class 1 Solvents (Associated with unacceptable toxicity)	Acceptance criteria is as per IP/ICH Q3C class 1 solvent	Acceptance criteria is as per BP/ ICH Q3C class 1 solvent	Acceptance criteria is as per USP/ ICH Q3C class 1 solvent

	Class 2 Solvents (Associated with less severe toxicity)	Acceptance criteria is as per IP/ICH Q3C class 2 solvent	Acceptance criteria is as per BP/ICH Q3C class 2 solvent	Acceptance criteria is as per USP/ ICH Q3C class 2 solvent


	Class 3 Solvents (Less toxic and of lower risk to human health)	Acceptance criteria is as per IP/ICH Q3C class 3 solvent	Acceptance criteria is as per BP/ICH Q3C class 3 solvent	Acceptance criteria is as per USP/ ICH Q3C class 3 solvent


9	Microbial Limit Test
	Total Aerobic Viable Count	1000 per g or per mL	1000 per g or per mL	1000 per g or per mL
	Total Fungal Count	100 per g or per mL	100 per g or per mL	100 per g or per mL
	*Escherichia* *coli*	Should be absent per 1 g	Should be absent per 1 g	Should be absent per 1 g
10	Impurities / Related substances
	a) For Drug substances	As per Table No. A	As per individual monograph (if not given then Inhouse Test limits should be applied: Substances for Pharmaceutical use. Ph Eur monograph)	As per individual monograph or Ordinary Impurities: NMT 2 % unless otherwise specified in the individual monograph.
	b) For Drug products	As per Table No. B	As per individual monograph (if not given then Inhouse Test limits should be applied: Substances for Pharmaceutical use. Ph Eur monograph)	As per individual monograph As per ICH/US FDA/ USP monograph submission guidelines. Ordinary Impurities: NMT 2 % unless otherwise specified in the individual monograph.

Table No. A: Reporting, identification and qualification of organic impurities in drug substances

Use	Maximum daily dose	Reporting threshold	Identification threshold	Qualification threshold
Human or Human and veterinary use	≤ 2 g	0.05%	0.10% (1.0 mg)^$	0.15 % (1.0 mg)^$
Human or Human and veterinary use	> 2 g	0.03%	0.05%	0.05%
veterinary use only	NA	0.1%^@#	0.2%^#	0.5%^#

$: Total daily intake (TDI; in parentheses) applies if it is lower than the calculated value.

@: Higher reporting thresholds should be scientifically justified.

#: Lower threshold can be appropriate if the impurity is unusually toxic

Table No. B: Reporting, identification and qualification of organic impurities or degradation products in drug products

Use	Maximum daily dose	Reporting threshold	Identification threshold	Qualification threshold
Human use	< 1 mg	0.10%	1.0 % (5 µg)^$	1.0 % (50 µg)^$
	≥ 1 to < 10 mg	0.10%	0.5% (20 µg)^$	1.0 % (50 µg)^$
	10 mg	0.10%	0.5% (20 µg)^$	0.5% (200 µg)^$
	> 10 - 100 mg	0.10%	0.2% (2 mg)^$	0.5% (200 µg)^$
	> 100 mg - 1 g	0.10%	0.2% (2 mg)^$	0.2% (3 mg)^$
	> 1 - 2 g	0.05%	0.2% (2 mg)^$	0.2% (3 mg)^$
	> 2 g	0.05%	0.10%	0.15%
veterinary use only	NA	0.3 %^#	1.0 %^#	1.0 %^#

$: Whichever is lower, calculated value or TDI (in parentheses).

#: Higher threshold should be scientifically justified.

CONCLUSION:

From the above review it is concluded that In Process Quality Control (IPQC) is a crucial component in the production of Oral solid dosage forms. It stands for the management of a product’s excellent quality. It is difficult for a product to survive in the market if the quality is not adequately maintained. For certain traditional dosage forms, IP, BP, and USP comprised the majority of the in process and finished product quality control testing. Nonetheless, several variations were noted. Certain tests are restricted to specific pharmacopoeias. The variations in the tests and their limitations as outlined in the various pharmacopoeias must be streamlined and harmonized so that, if the test satisfies the defined limit as per the harmonized one, it satisfies all requirements of all pharmacopoeias and, subsequently, all regulatory requirements of that specific nation. This is crucial for products that are sold all over the world. This reduces the need for a significant amount of time, money, and labor.

ACKNOWLEDGEMENTS:

The authors would like to express their sincere gratitude to the Research and Development team at Zuventus Healthcare Limited for their valuable insights and support during the preparation of this review article.

FINANCIAL DISCLOSURE STATEMENT: The author received no specific funding for this work.

CONFLICTS OF INTEREST:

The authors declare no conflict of interest.

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Received on 21.12.2024 Revised on 18.01.2025

Accepted on 07.02.2025 Published on 03.03.2025

Available online from March 07, 2025

Asian J. Res. Pharm. Sci. 2025; 15(1):68-76.

DOI: 10.52711/2231-5659.2025.00010

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