Chemical | |||
Specific Tests and/or Properties Measured | Specification, Standard, Method, or Test Technique | Items, Materials or Product Tested | Key Equipment or Technology |
Chromatography HPLC | Current USP-NF < 621> British Pharmacopeia VA240, International pharmacopeia; 1.14.1 and Pharmaceutical monographs | Pharmaceutical and related products | HPLC |
Loss on Drying (LOD) | Current USP-NF < 731> British Pharmacopeia V-A358, International Pharmacopoeia; General Notices and Pharmaceutical Monographs | Pharmaceutical and related products | Oven Analytical Balances |
Dissolution | Current USP-NF < 711> British Pharmacopeia VA413 for tablet @ capsule, International Pharmacopeia 5.5 and Pharmaceutical monographs | Pharmaceutical and related products | Dissolution system HPLC Spectrophotometer |
Spectrophotometry | Current USP-NF <1857> British Pharmacopeia V-A192, International Pharmacopeia 1.6 and Pharmaceutical monographs | Pharmaceutical and related products | UV/VIS Spectrophotometer |
pH | Current USP-NF < 791> British Pharmacopeia V-A917 Pharmaceutical, International Pharmacopeia; 1.13 and monographs | Pharmaceutical and related products | pH meter |
KF Water Determination | Current USP-NF <921>, British Pharmacopeia V-A165, International Pharmacopeia 2.8 and Pharmaceutical Monographs | Pharmaceutical and related products | KF Analytical Balances |
Uniformity of Dosage Unit
| Current USP-NF< 905> British Pharmacopeia VA433, International Pharmacopoeia 5.2 and Pharmaceutical monographs | Pharmaceutical and related products | HPLC Analytical Balances Spectrophotometer |
Friability Test | Current USP-NF <1216> British Pharmacopeia VA603, International Pharmacopoeia and Pharmaceutical Monograph | Pharmaceutical and Related Products | Friability Tester |
Hardness Test | Current USP-NF <1217> British Pharmacopeia VA606 and Pharmaceutical Monograph | Pharmaceutical and Related Products | Hardness Tester |
Disintegration Test | Current USP-NF <701> British Pharmacopeia VA606, International Pharmacopoeia 5.3 and Pharmaceutical Monograph | Pharmaceutical and Related Products | Disintegration Tester |
Volumetric Titration | Current USP-NF <541> British Pharmacopeia VA916, International Pharmacopoeia A.4 and Pharmaceutical Monograph | Pharmaceutical and Related Products | Titration |
Optical Rotation | Current USP-NF <781>, British Pharmacopeia VA282, International Pharmacopoeia 1.4 and Pharmaceutical Monographs | Pharmaceutical and Related Products | Polarimetry |
FTIR | Current USP-NF <197> British Pharmacopeia VA184, International Pharmacopoeia 1.7 and Pharmaceutical Monographs | Pharmaceutical and Related Products | FTIR system |