N-Acetylcysteine (NAC) & amino acid APIs · GMP plant · DMF / WC / COPP available
Sales: +86 187 2164 5330 angela@hichibiopharma.com
CAS 616-91-1 · ChP, USP, EP, BP, AJI · GMP

N-Acetyl-L-Cysteine

CAS No. 616-91-1 · Molecular formula C5H9NO3S · Molecular weight 163.20 g/mol
ChPUSPEPBPAJIDMFWCCOPPCEP In application
CH3CONHCHCH2SHCOOH

A thiol-containing amino acid derivative supplied as a white crystalline powder. Used as an active pharmaceutical ingredient in mucolytic preparations and as a functional ingredient in food and nutraceutical applications.

Supplied as a raw material for further manufacturing. No therapeutic, efficacy or dosage claim is made or implied on this site. A DMF is a submission filed with the authority — it does not constitute approval by any regulatory agency.

Request a Quote

Please state grade, quantity and destination country. Quotation with COA sample and MSDS within 24 hours.

Or reach us directly
angela@hichibiopharma.com
WhatsApp +86 187 2164 5330

Typical applications

Specification

ItemSpecificationMethod / standard
AppearanceWhite crystalline powderChP / USP / EP
Assay (dried basis)Within current pharmacopoeia limitsChP / USP / EP
Specific rotationOn requestUSP / EP
Loss on dryingOn requestUSP / EP
Heavy metalsOn requestICH Q3D
Related substancesOn requestHPLC
MicrobiologyOn requestChP / USP / EP

Available grades

GradeStandardTypical use
Pharmaceutical (API)ChP · USP · EP · BP · AJIMucolytic preparations, inhalation solutions
Food gradeFCC · AJIFood & beverage, functional ingredients
Nutraceutical gradeFCC · in-houseDietary supplement formulations
Custom specificationas agreedParticle size, packing and specification on request

Documents & regulatory package

DocumentStatus
Certificate of Analysis (COA) — 3 commercial batchesAvailable
Drug Master File (ChP / USP / EP)Available
Written Confirmation (WC) — EUAvailable
COPPAvailable
GMP certificateAvailable
CTD Module 3 (S.1–S.7)Available
Stability data — ICH Q1A, Zone II & IVbAvailable
TSE / BSE & GMO free statementAvailable
ICH Q3C / Q3D & nitrosamine assessmentAvailable
CEP (EDQM)In application
Letters of access (LOA) for DMF are released case by case after a confidentiality agreement, not from a public download area.

Packing, storage & logistics

ItemDetail
Packingfibre drum (PE liner)
StorageSealed, protected from light, dry place
Shelf lifePer stability data (Zone II & IVb)
TransportAmbient / cold chain on request
Lead timeOn request — depends on grade & quantity
MOQ / sampleSample available; MOQ on request

Supply capability

  • Batch traceability from raw material to finished product
  • Sealed pipeline process with 12,700 DCS control points
  • Scale-up from gram-level samples to commercial volumes
  • On-site and remote audits accepted
  • Documentation package prepared for your registration dossier

Downloads

NAC specification (PDF) · COA sample (PDF) · MSDS / SDS

Related products

L-Cysteine

CAS 52-90-4 · AJI, JP

L-Cysteine HCl Monohydrate

CAS 7048-04-6 · CP, EP, USP, AJI

Carbocisteine (S-CMC)

CAS 638-23-3 · EP, CP, JP

L-Cystine

CAS 56-89-3 · AJI, FCC

FAQ

QuestionAnswer
Can I get a sample before ordering?Samples are supplied with COA. Sample cost is deductible from the first commercial order.
Which pharmacopoeia standards do you supply?ChP, USP, EP, BP, AJI and FCC. Please state the edition you need when enquiring.
Which documents ship with the goods?COA and MSDS as standard, plus the regulatory documents agreed in the contract.
Do you accept customer audits?Yes. Please notify us at least two weeks in advance.

Send us your specification — quotation within 24 hours

Tell us grade, pharmacopoeia, quantity and destination. We reply with COA sample, MSDS and a price proposal.