The documentation package released with N-Acetylcysteine shipments, and what can be issued on request.
| Document | Status |
|---|---|
| Certificate of Analysis (COA) — 3 commercial batches | Available |
| Drug Master File (ChP / USP / EP) | Available |
| Written Confirmation (WC) — EU | Available |
| COPP | Available |
| GMP certificate | Available |
| CTD Module 3 (S.1–S.7) | Available |
| Stability data — ICH Q1A, Zone II & IVb | Available |
| TSE / BSE & GMO free statement | Available |
| ICH Q3C / Q3D & nitrosamine assessment | Available |
| CEP (EDQM) | In application |
Tell us grade, pharmacopoeia, quantity and destination. We reply with COA sample, MSDS and a price proposal.
