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Batch Certification: ZP-ITR100-2410

Authenticity Verified
Antifungal

Zesstrac 100mg Capsule

Itraconazole 100mg

QC Release Status APPROVED & RELEASED
Batch Code ZP-ITR100-2410
Certificate No COA-ZP-2410-01
Manufacturing Date 10/2024
Expiry Date 09/2026
Purity Assay Score 99.82%
Pharmacopoeial Standard Complies with Indian Pharmacopoeia (IP)
Microbiological Test Complies with Pharmacopoeial Limits (Pathogen Free)
Heavy Metals Complies (Within Permissible WHO Limits)
Manufacturing Facility Unit II, Pharma Industrial Zone, Solan (HP)
Quality Testing Facility Zess Pharma Quality Control & NABL Accredited Testing Partner

Official Certificate of Analysis (CoA)

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
Approved & Released by Zess Pharma Central QA Standard: Indian Pharmacopoeia (IP)
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