Quality & Compliance
Regulated buyers depend on more than a purity figure. They depend on documentation, traceability and consistency they can defend in an audit. Astrabio builds quality into every batch, from incoming material to controlled release.
Quality is a culture, not a checkpoint
Founded by scientists in 2020, Astrabio treats quality as a discipline that runs the length of the supply chain, not a final inspection bolted on at the end. Every product line is governed by documented procedures, analysed on validated instrumentation and released only against a defined specification. The result is material you can qualify with confidence and reorder without surprises.
Across our headquarters, factory and R&D centre, the same standards apply: measure it, document it, trace it, and stand behind it.
- Documented, batch-specific records for every shipment
- HPLC-verified purity, typically ≥ 98%, confirmed before release
- Full traceability from raw material to finished lot
- Consistent specifications, batch after batch
- Retained samples and controlled storage conditions
- Documentation prepared to support your regulatory filings
Independently audited management systems
Our operations are governed by internationally recognised ISO standards, audited by external bodies. Full certificates are available to qualified customers on request.
Quality Management System: process control, traceability and continuous improvement across every product line.
Environmental Management: responsible handling of materials, waste and resources throughout our sites.
Occupational Health & Safety: a safe, controlled working environment that protects people and product.
What a Certificate of Analysis looks like
Every batch ships with a batch-specific CoA. Below is a real certificate from a recent lot, issued by our analytical laboratory.
Click to enlarge
Bilingual, batch-specific, audit-ready
Each certificate states the batch analysed, the specification each test was released against and the result obtained, in English and Chinese. Identity, purity, impurity profile and water content are all reported against defined acceptance criteria, so your incoming QC team can verify the material against the same numbers we released it on.
Certificates are issued per batch, not per product: reordering the same compound gives you a new document tied to the lot you actually received. Retained samples let us re-test if a question comes up later.
Analytical testing by ALWSCI Technologies Co., Ltd.
Request a CoA for your batchThe documentation your team expects
Complete paperwork ships as standard, with deeper technical and regulatory support available on request to keep your qualification and filings moving.
Certificate of Analysis (CoA)
Batch-specific results against the agreed specification: identity, purity, impurities and key physical parameters.
Safety Data Sheet (MSDS/SDS)
Globally formatted safety documentation covering handling, storage, transport and hazard classification.
Specification sheet
A clear definition of the acceptance criteria each batch is tested and released against.
Stability data on request
Storage and stability information to support your shelf-life assessment and material qualification.
Method & analytical details
Chromatograms and method information available to help you verify results and set up incoming testing.
DMF references where available
Drug Master File references and regulatory support to help your submissions and audits progress.
Need our CoA, MSDS or a qualification sample?
Tell us the product, quantity and documents you require. Our technical team replies within one business day with specifications, available data and a sample offer where relevant.