Quality & compliance
Built around one number: DCA ≤ 0.2 %
Quality control
What is controlled, and why
Process statements to be confirmed by the plant
01
Impurity control at the reactor
Dichloroacetic acid forms alongside MCA during chlorination. Keeping it at or below 0.2 % is a matter of reaction control and separation, not blending — so every lot is tested for DCA before release.
02
Lot-wise Certificate of Analysis
Each lot ships with a COA stating the tested values against the agreed specification. Retained samples are kept for the shelf-life period.
03
Moisture and handling
MCA is hygroscopic and corrosive. Packing, sealing and storage are managed to keep moisture pick-up low between the plant and the customer's reactor.
04
Change control and traceability
Raw-material lots, batch records and COAs are traceable from the customer's lot number back to the acetic acid and chlorine inputs.
Documentation
Available on request
- On request
Certificate of Analysis (COA)
Lot-wise, against the agreed specification
- On request
Technical Data Sheet (TDS)
Specification, properties, packaging, storage
- On request
Safety Data Sheet (SDS)
GHS / CLP format; EU and US layouts
- On request
Certificate of Origin (CoO)
Issued per shipment through the chamber of commerce
- On request
Specification sheet / supplier questionnaire
Completed on request for vendor qualification
- On request
Method of analysis for DCA
Shared under NDA for method transfer
Certifications & registrations
Status, stated plainly
| Item | Scope | Status |
|---|---|---|
| ISO 9001 | Quality management system | TBC |
| ISO 14001 | Environmental management | TBC |
| ISO 45001 | Occupational health & safety | TBC |
| EU REACH | Registration via Only Representative, or supply to registered importers | TBC |
| US TSCA | Inventory certification statement with US shipments | TBC |
| Halal / Kosher | For SE Asian and Middle-East buyers | TBC |
| Pollution-control consent (TSPCB) | Consent to operate — Choutuppal site | TBC |
Regulatory statements for a specific shipment (REACH supply route, TSCA inventory status, certificate of origin) are issued in writing with the quotation.
EHS
Environment, health & safety
The Choutuppal site handles chlorine, acetic acid and hydrogen chloride off-gas under written procedures for corrosive and toxic materials. Details of consents, effluent and HCl handling and emergency response are shared with customers during vendor qualification.
Audits
Customer audits
LVK welcomes customer audits and supplier questionnaires as part of vendor qualification.
FAQ
Quality — questions buyers ask
- What is pharmaceutical-grade monochloroacetic acid?
- Pharmaceutical-grade monochloroacetic acid is MCA (CAS 79-11-8) produced and released to a tighter impurity specification for API and intermediate synthesis — above all a low limit on dichloroacetic acid (DCA), the over-chlorination by-product that carries through many syntheses. LVK Pharma's pharma grade is released at DCA ≤ 0.2 %; the full specification (assay, moisture, colour, iron, sulphate, chloride, residue on ignition) is stated on the Technical Data Sheet, available on request.
- What is dichloroacetic acid (DCA) and why does it matter as an impurity in MCA?
- Dichloroacetic acid (DCA, CAS 79-43-6) is acetic acid with two chlorines; it forms alongside monochloroacetic acid when chlorination runs past the mono stage. It matters because DCA reacts in the same way as MCA and produces dichloro by-products that are hard to remove from an API or intermediate, and because DCA is itself toxic. Pharmaceutical buyers therefore specify a DCA limit; LVK Pharma controls it at the reactor and releases its pharma grade at DCA ≤ 0.2 %.
- What is on a Certificate of Analysis for monochloroacetic acid?
- A Certificate of Analysis (COA) for monochloroacetic acid states the tested results of a specific lot against the agreed specification: assay (% MCA), dichloroacetic acid, moisture, colour (APHA), iron, sulphate, chloride and residue on ignition, each with its limit, result and test method, plus lot number, manufacturing date and the release signature. LVK Pharma can share a sample COA on request for vendor qualification.
- How is the DCA content of monochloroacetic acid tested?
- Dichloroacetic acid in monochloroacetic acid is normally determined by gas chromatography or HPLC after derivatisation or direct injection, with a limit expressed as a percentage of the sample; titration methods measure total acidity but cannot separate DCA from MCA. Method details for DCA testing can be discussed with a customer's QC laboratory during vendor qualification. The DCA limit for the pharma grade is ≤ 0.2 %.
- Which certifications and registrations does LVK Pharma hold?
- LVK Pharma states certification and registration status in writing per enquiry and claims nothing on this website that has not been confirmed. The Quality page lists the items export buyers ask about — ISO 9001, ISO 14001, ISO 45001, the EU REACH supply route, a US TSCA inventory statement, Halal/Kosher and the Telangana pollution-control consent — with their current status. Regulatory statements for a specific shipment are issued with the quotation.
- Does LVK Pharma accept supplier questionnaires and customer audits?
- Yes. Supplier questionnaires and vendor-qualification forms are completed on request, and customer audits can be arranged as part of vendor qualification. The standard qualification pack — Technical Data Sheet, GHS/CLP Safety Data Sheet, a sample Certificate of Analysis and the regulatory statements relevant to the destination market — is sent with or ahead of the quotation. Use the contact form to send a questionnaire or request the documents.
Start vendor qualification
Request the TDS, SDS and a sample COA, or send your supplier questionnaire.