Submission Date: July 6, 2026
Submitted By: UDENSON BLESSING
Registered Number: 2023654114
Department: Phamaceutical Chemistry
Subject: Comparative Compendial Specifications (USP, Ph. Eur.,
BP)
SECTION 1: UNITED STATES PHARMACOPEIA (USP)
SPECIFICATIONS
1.1 Active Pharmaceutical Ingredients (APIs)
# API Name Compendial Assay/Purity Specific
Source Limit Impurity &
(Dried/Anhydro Limit
us Basis) Thresholds
1 Aspirin(Acetyls USP Monograph 99.5% – 100.5% • Free Salicylic
alicylic Acid) Acid: ≤ 0.1%
• Total organic
impurities: ≤
0.05%
2 Metformin USP Monograph 98.5% – 101.0% •
Hydrochloride Cyanoguanidine
: ≤ 0.02%
• Any single
unspecified
impurity: ≤
0.10%
3 Atorvastatin USP Monograph 98.0% – 102.0% • Atorvastatin
Calcium epoxide: ≤
0.15%
• Total individual
unspecified
impurities: ≤
0.10%
4 Prednisone USP Monograph 97.0% – 102.0% • Formyl
prednisolone: ≤
0.15%
• Total
impurities: ≤
1.0%
5 Simvastatin USP Monograph 98.0% – 102.0% • Lovastatin: ≤
1.0%
• Single
unspecified
impurity: ≤
0.10%
• Total
impurities: ≤
1.5%
1.2 Finished Pharmaceutical Products (FPPs)
# Finished Dosage Form Assay Limit (% Degradation /
Product Name of Labeled Product
Claim) Impurity Limits
1 Acetaminophen Capsule 90.0% – 110.0% • 4-aminophenol
Capsules (storage
degradation): ≤
0.1%
2 Ibuprofen Tablet 90.0% – 110.0% •
Tablets 4-isobutylacetop
henone
degradation
product: ≤ 0.2%
3 Amoxicillin Capsule 90.0% – 120.0% • Total
Capsules degradation
products: ≤ 5.0%
4 Metformin HCl ER Tablet 95.0% – 105.0% •
Extended-Relea Cyanoguanidine
se : ≤ 0.05%
5 Ciprofloxacin Tablet 90.0% – 110.0% • Ciprofloxacin
Tablets ethylenediamine
analog: ≤ 0.5%
SECTION 2: EUROPEAN PHARMACOPOEIA (PH. EUR.)
SPECIFICATIONS
2.1 Active Pharmaceutical Ingredients (APIs)
# API Name Compendial Assay/Purity Specific
Source Limit Impurity &
(Dried/Anhydro Limit
us Basis) Thresholds
1 Amoxicillin Ph. Eur. 95.0% – 102.0% • Impurity D
Trihydrate Monograph (Penicilloic
acids): ≤ 1.0%
• Any other
single impurity: ≤
0.15%
2 Diclofenac Ph. Eur. 99.0% – 101.0% • Impurity A
Sodium Monograph (indolin-2-one
derivative): ≤
0.15%
• Total
impurities: ≤
0.20%
3 Omeprazole Ph. Eur. 99.0% – 101.0% • Impurity H
Monograph (omeprazole
sulfone): ≤
0.15%
• Any single
unspecified
impurity: ≤
0.10%
4 Caffeine Ph. Eur. 98.5% – 101.0% • Impurity A
Anhydrous Monograph (theophylline): ≤
0.10%
• Total related
substances: ≤
0.10%
5 Losartan Ph. Eur. 98.5% – 101.5% • Impurity J
Potassium Monograph (chloromethyl
imidazole
derivative): ≤
0.15%
• Total
impurities: ≤
0.30%
2.2 Finished Pharmaceutical Products (FPPs)
# Finished Dosage Form Assay Limit (% Degradation /
Product Name of Labeled Product
Claim) Impurity Limits
1 Ascorbic Acid Tablet 95.0% – 105.0% • Oxalic acid
Tablets degradation
byproduct: ≤
0.2%
2 Paracetamol IV Infusion 95.0% – 105.0% •
Infusion 4-aminophenol:
≤ 0.05%
• Total
degradants: ≤
0.10%
3 Diazepam Injection 95.0% – 105.0% •
Injection 2-amino-5-chlor
obenzophenone:
≤ 0.10%
4 Pantoprazole GR Tablet 95.0% – 105.0% • Any individual
Gastro-Resista degradation
nt product: ≤ 0.2%
• Total
degradants: ≤
0.5%
5 Atorvastatin Tablet 95.0% – 105.0% • Impurity E
Tablets (Atorvastatin
diketoarene): ≤
0.15%
SECTION 3: BRITISH PHARMACOPOEIA (BP) SPECIFICATIONS
3.1 Active Pharmaceutical Ingredients (APIs)
# API Name Compendial Assay/Purity Specific
Source Limit Impurity &
(Dried/Anhydro Limit
us Basis) Thresholds
1 Paracetamol(Ac BP Monograph 99.0% – 101.0% •
etaminophen) 4-aminophenol:
≤ 0.005% (50
ppm)
•
Chloroacetanilid
e: ≤ 0.001% (10
ppm)
2 Ibuprofen BP Monograph 98.5% – 101.0% • Impurity A
(4-isobutylaceto
phenone): ≤
0.1%
• Any other
individual
impurity: ≤ 0.1%
3 Fluoxetine BP Monograph 98.0% – 101.5% • Impurity B
Hydrochloride (chiral
isomer/epimer
mix): ≤ 0.15%
• Total
impurities: ≤
0.30%
4 Erythromycin BP Monograph 93.0% – 102.0% • Erythromycin
B: ≤ 12.0% |
Erythromycin C:
≤ 5.0%
• Any other
single impurity: ≤
3.0%
5 Hydrochlorothi BP Monograph 98.0% – 102.0% • Chlorothiazide
azide impurity: ≤ 0.5%
• Total individual
unspecified
impurities: ≤
0.10%
3.2 Finished Pharmaceutical Products (FPPs)
# Finished Dosage Form Assay Limit (% Degradation /
Product Name of Labeled Product
Claim) Impurity Limits
1 Paracetamol Tablet 95.0% – 105.0% • 4-aminophenol
Tablets (finished product
tolerance): ≤
0.1%
2 Aspirin Tablets Tablet 95.0% – 105.0% • Salicylic acid
degradation
compound: ≤
0.3%
3 Amoxicillin Oral Liquid 92.5% – 107.5% • Total related
Oral substances
Suspension (hydrolysis
degradants): ≤
4.0%
4 Morphine Injection 92.5% – 107.5% •
Sulfate Pseudomorphin
Injection e degradation
product: ≤ 1.5%
5 Codeine Tablet 95.0% – 105.0% • Morphine
Phosphate (unreacted/degr
Tablets aded alkaloid): ≤
0.1%