Cetirizine Hydrochloride CAS 83881-52-1 API Candidate, ≥99% / USP-Oriented Specs
Buyer-facing sourcing candidate for Cetirizine Hydrochloride, CAS 83881-52-1, offered as a white powder with stated purity ≥99% and USP 45-NF 40 style test references. The listing should be treated as a verification candidate: buyers should confirm the correct CAS number, pharmacopeial grade, API manufacturing status, impurity profile, COA batch data, GMP/document readiness, packing format, export eligibility, and destination-country import requirements before RFQ or qualification.
Quick buying facts
Identify the grade, package, and import market before comparing suppliers.
Use this page to check the product identity, common specification points, document scope, package notes, and destination-market questions before sending a China sourcing request.
CAS discrepancy on source page: 83881-51-0 also appears and must be clarified before quotationPharmaceutical API / active ingredient raw material candidateHuman review
CAS discrepancy on source page: 83881-51-0 also appears and must be clarified before quotation
Molecular formula listed: C21H25ClN2O3
Appearance: white powder
Assay / purity: stated ≥99%; table indicates USP-style assay range 98.0%–102.0% by HPLC
Identification: IR conforms to reference spectrum; HPLC retention time matches reference standard
Loss on drying: listed limit ≤0.5%
Residue on ignition: listed limit ≤0.1%
Heavy metals: listed limit ≤20 ppm
Related substances: individual impurity ≤0.1%; total impurities ≤0.5%
pH: 4.0–5.5 for 1% w/v aqueous solution
Who uses this page
Target buyers
Pharmaceutical API distributors
Finished dosage form manufacturers requiring qualified API sourcing
Regulatory affairs and procurement teams screening China-origin API suppliers
Contract manufacturing organizations sourcing antihistamine API inputs
Importers requiring document-ready pharmaceutical raw material candidates
Before matching
Documents to check
CAS number, grade, assay, and impurity profile
SDS, COA, TDS, HS code, and transport classification
Destination-market import documents before supplier matching
Package and route
Packing notes
Listed transport package: bags
Listed specification: 25 kg/bag
Confirm whether inner pharmaceutical-grade liner, tamper-evident closure, and moisture barrier packaging are available
Confirm availability of customer-specific labeling, batch number, net/gross weight, manufacture date, retest date, and country-of-origin marking
Request palletization, carton/drum alternatives, and export carton marks if required by destination market
Confirm sample packing format and whether sample COA matches commercial production batch standards
Applications and sourcing options
Check whether this product fits the buyer's actual application.
Clear application, grade, package, and document notes help separate real sourcing demand from a vague price check.
Use context
Common applications
Supplier pre-qualification for Cetirizine Hydrochloride API sourcing
RFQ preparation with CAS, assay, impurity, packing, and document requirements
Comparison of USP/EP-aligned API offers from China-based suppliers
Commercial batch qualification subject to regulatory and quality review
Document gap check before sample approval or purchase order
How we compare
Sourcing options
Request a document-first quotation including COA, SDS, specification, GMP/document status, and packing details
Ask for a small qualification sample only after CAS and grade are confirmed
Require third-party testing for identity, assay, related substances, and residual solvents before approving bulk order
Compare offers from direct GMP manufacturers versus trading companies with disclosed manufacturing source
Use conditional RFQ language: quotation subject to destination-country import eligibility and buyer quality approval
Human review
Compliance notes
This is a pharmaceutical API candidate and should not be sourced as an agrochemical technical material without clarifying intended regulatory classification
Verify supplier role: manufacturer, trading company, or distributor; source page identifies the supplier as a trading company
Request GMP status, manufacturing site details, quality agreement options, audit documents, and change-control statement where applicable
Request current COA, specification sheet, MSDS/SDS, TDS, impurity statement, residual solvent statement, elemental impurity statement, allergen/BSE-TSE statements if needed, and country-specific regulatory support documents
No regulatory approval or market authorization should be assumed from the listing
Confirm export controls, customs code, pharmaceutical import permits, and destination-country API registration requirements before shipment
HS code listed: 2933599090; buyer should validate classification with customs broker
Dangerous goods status is not confirmed on the source page; request SDS transport section and carrier acceptance before booking
Buyer search paths
Related sourcing terms
These terms support long-tail discovery while keeping the page focused on useful product and China export buying context.
Cetirizine Hydrochloride CAS 83881-52-1Cetirizine HCl API supplier ChinaCetirizine Hydrochloride USP gradeCetirizine HCl COA SDSCetirizine Hydrochloride impurity profilepharmaceutical API sourcing Chinaantihistamine API raw materialCAS 83881-52-1 API candidate
Related product options
Build a broader quote package from adjacent options.
Buyers often compare neighboring grades, forms, or route options before sending one consolidated RFQ.
Share target market, quantity, packaging scope, artwork status, delivery destination, and required documents so CHN Chemicals can prepare a cleaner supplier comparison.
Questions to confirm
Please confirm the correct CAS number for the quoted material: 83881-52-1 or 83881-51-0?
Is the material offered as Cetirizine Hydrochloride API grade, pharmacopeial grade, intermediate grade, or research/industrial grade?
Can you provide a recent batch COA with actual numerical results for assay, related substances, residual solvents, water/loss on drying, residue on ignition, heavy metals/elemental impurities, and microbiological tests if applicable?
Which pharmacopeia is the release specification aligned with: USP, EP, BP, JP, in-house, or customer specification?
What is the manufacturing site name and address, and is it GMP certified or audited by any recognized authority?
Are DMF, CEP, WC, GMP certificate, audit report, quality questionnaire, and change-control documents available for qualified buyers?
What are the named and unknown impurity limits, and can you provide impurity method validation or chromatograms on request?
What residual solvent class limits are controlled, and which solvents are monitored in routine release?
Checks before quote
This is a pharmaceutical API candidate and should not be sourced as an agrochemical technical material without clarifying intended regulatory classification
Verify supplier role: manufacturer, trading company, or distributor; source page identifies the supplier as a trading company
Request GMP status, manufacturing site details, quality agreement options, audit documents, and change-control statement where applicable
Request current COA, specification sheet, MSDS/SDS, TDS, impurity statement, residual solvent statement, elemental impurity statement, allergen/BSE-TSE statements if needed, and country-specific regulatory support documents
No regulatory approval or market authorization should be assumed from the listing
Confirm export controls, customs code, pharmaceutical import permits, and destination-country API registration requirements before shipment
HS code listed: 2933599090; buyer should validate classification with customs broker
Dangerous goods status is not confirmed on the source page; request SDS transport section and carrier acceptance before booking
Next step
Send the product page with your target quantity and market. A sourcing manager can then confirm sample options, supplier fit, packaging details, and open document gaps.