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Document Ref: COA-ZP-2410-01 • Issued: 12 Oct 2026
Itraconazole 100mg
NABL Accredited Analytical Quality Release Document
| Parameter | Pharmacopoeial Spec | Observed Result | Verdict |
|---|---|---|---|
| Description | Hard gelatin capsules with white pellets | Complies | PASSED |
| Identification (HPLC) | Matches Reference Standard | Conforms | PASSED |
| Average Net Fill Weight | 420.0 mg ± 5% | 421.3 mg | PASSED |
| Uniformity of Dosage Units | AV ≤ 15.0 | AV = 3.2 | PASSED |
| Dissolution Rate (45 min) | NLT 75% | 84.6% | PASSED |
| Assay (Itraconazole) | 90.0% – 110.0% | 99.82% | PASSED |
| Related Substances | NMT 1.0% | 0.18% | PASSED |
| Microbiological Limits | Pathogens Absent | Absent (< 50 CFU/g) | PASSED |
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