Chemical Quality Control & Product Documentation
How a batch is analysed, documented and released — and what you receive with every shipment.
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Chemical Quality Review from Material to Release
01 / Raw materials
Confirm the material and agreed specification before production.
02 / In-process checks
Follow the controls agreed for the product and process.
03 / Finished-product testing
Compare analytical results with the agreed product specification.
04 / Review & release
Review the data and connect the released lot to its documentation.
Chemical Sample Evaluation & Batch Documentation
01
Sampling
Retained sample pulled from the lot and logged against the batch record.
02
Analysis
Review the analytical result against the agreed specification before a release decision.
03
Review
QC reviewer checks the data package and signs the CoA.
04
Release & retain
Confirm release, the applicable CoA and any retention requirements for the product.
【待客户提供：检测设备清单；名称、数量、型号及自有/委外归属，Excel；用于检测能力表】
【待客户提供：HPLC 方法清单；适用产品、方法编号、版本、检测项目与限值，可脱敏 SOP/PDF；用于液相检测说明】
【待客户提供：GC 方法清单；适用产品、方法编号、版本、检测项目与限值，可脱敏 SOP/PDF；用于气相检测说明】
【待客户提供：KF 方法清单；适用产品、水分测试方法编号、版本与限值，可脱敏 SOP/PDF；用于水分检测说明】
【待客户提供：滴定方法清单；适用产品、滴定项目、方法编号、版本与限值，可脱敏 SOP/PDF；用于含量检测说明】
【待客户提供：留样期限；各产品留样时长、数量、储存条件及起算日，SOP 摘要或负责人确认文字；用于留样制度说明】
【待客户提供：OOS 处理；超标结果的复核、调查、审批、处置及客户沟通流程，SOP 摘要；用于异常结果说明】
【待客户提供：放行标准；各产品适用规格、限值、判定规则及批准责任人，可脱敏规格表/PDF；用于批次放行说明】
【待客户提供：可公开检测样本；与设备和方法对应的脱敏检测记录或报告 PDF；用于质量能力举证】
Chemical Analytical Methods & Laboratory Information
The test panel follows the product and your specification. Instrument availability and method summaries are confirmed during supplier qualification.
待客户提供：设备型号、自有或委外归属、对应产品的检测方法及可公开样本。
What Is Checked Before a Lot Is Released
The test panel follows the product and your specification. This is the typical structure, not a fixed list of limits.
Check · Applies to · How it is verified · Where it is recorded
Identity
As agreed for the product
FTIR or NMR against an authenticated reference
CoA + analytical file
Assay / purity
As agreed for the product
HPLC area% or titration, depending on the product
CoA
Impurity profile
As agreed for the product
HPLC area normalisation; individual and total impurities
CoA
Water content
Where the specification sets a limit
Karl Fischer titration
CoA
Residual solvents
Where the route uses class 1/2 solvents
GC headspace
CoA or statement
Appearance
As agreed for the product
Visual against the reference sample
CoA
Heavy metals / elemental
On request or per customer spec
ICP-MS or ICP-OES
CoA
The parameters and limits applied to your order are the ones in the quotation and the specification sheet — not a generic list.
What We Control Before Release
The product page gives you the specification. This page explains how we prove it, lot after lot.
01
In-house QC laboratory
Confirm the analytical methods and quality checks against the product specification. Relevant items may include purity, residual solvents, water, titration or melting point where applicable.
02
Batch traceability
Agree on the product and batch references, relevant process and analytical records, and any retention requirements for the order.
03
Certificate of Analysis
A CoA is issued per lot with the tested parameters, specification limits, results and methods used. Customised CoA formats are available on request.
04
Supplier qualification
Review supplier documentation, sample results and relevant quality information against the agreed sourcing requirements.
Confirm which supplier records can be shared and any confidentiality arrangements that apply.
Samples We Keep
Retention samples let a dispute be settled months after delivery instead of by argument.
Retention sample
Confirm whether retention samples apply to the product, together with the sample quantity, batch reference, storage conditions and retention period.
Stability
Where a product has a defined retest period, it is stated on the TDS. Products without one are treated as stable under the storage conditions on the SDS, and re-analysed on request before a repeat order ships.
Management Systems & Registrations
Request the document appropriate to the product and named legal entity. Check its stated scope and date.
ISO 9001
Quality management
ISO 14001
Environmental management
GMP
Where applicable to the product
REACH
Registration status by substance
When a Result Fails
An out-of-specification result stops the release. There is no discretionary override on the shop floor.
01
Retest
The sample is re-prepared and re-injected to rule out an analytical error.
02
Investigation
If the result repeats, the batch is investigated: raw materials, process deviation, equipment.
03
Decision
The lot is either reworked under a documented procedure or rejected; it is never released as-is.
04
Customer contact
If the lot was already allocated to you, we tell you before shipment and offer the options.
Chemical Quality & Documentation FAQs
Yes. Send the product and the specification you need to meet; we return a sample CoA from a recent lot, and the final CoA is issued for the lot we ship.
Send your analytical data and the method used. We compare against the retained sample and the release data, then either re-test or replace the material.
Yes, subject to scheduling and an NDA. We share the QC records, retention-sample policy and supplier qualification process for the products you buy.
Request a CoA, TDS or SDS
Tell us the product and the document you need. If a document does not exist yet for that product, we say so instead of sending a generic sheet.
Can’t Find the Chemical You Need?
Share the product name, CAS number or specifications so we can assess sourcing or custom development options.