阿拉丁试剂的规格、级别和纯度

Analytical Standard Grade

Certified Reference Materials for Quantitative and Qualitative Analysis


Analytical Standard Grade products from Aladdin Scientific are high-purity chemicals and solutions developed for use as primary or secondary reference standards in a wide range of analytical testing, method validation, and instrument calibration workflows. Each compound is supplied with full documentation supporting its use in traceable, reproducible, and regulated analytical applications.


Key Features

· High Chemical Purity (Typically ≥99.5%)
Precisely characterized and controlled to ensure lot-to-lot reproducibility.

· Accurate Composition and Traceability
Identity and concentration verified by NMR, HPLC, GC, MS, KF, or titration methods. Traceable to international or pharmacopeial reference materials (where applicable).

· Accompanied by Detailed Certificate of Analysis (CoA)
Includes molecular identity, purity, assay method, water content, residual solvents, and measurement uncertainty (for certified reference materials).

· Stability and Packaging
Packaged under inert atmosphere or sealed in ampoules to preserve stability and concentration over time. Suitable for long-term archival and use in regulated environments.


Typical Applications

· Calibration of analytical instruments (HPLC, GC, LC-MS, UV-Vis)

· Standard curve generation for quantitative assays

· Method validation and system suitability testing

· Regulatory and compendial testing (e.g., pharmacopeial, environmental, forensic)

· Control of process consistency in QA/QC laboratories


Available Formats

· Neat solids or liquids (≥99.5% purity)

· Pre-weighed ampoules or solution standards (e.g., 1000 µg/mL in MeOH or ACN)

· Custom concentrations, blends, and multi-component standards available on request


Why Choose Aladdin Analytical Standards?

· Manufactured in ISO-compliant and traceable labs

· Backed by complete characterization and validated methodology

· Ideal for use in GLP, GMP, ISO/IEC 17025, and regulatory compliance testing

· Supplied with CoA and optional SDS, IR/NMR/MS spectra


Standard Grade Comparison Analytical vs CRM vs USP vs Working

Attribute

Analytical Standard Grade

Certified Reference Material (CRM)

USP/EP Standard

Working Standard

Typical Purity

≥99.5%

≥99.9% or certified value

Defined by pharmacopeial monograph

Varies (often ≥98%)

Traceability

Traceable to reference compound (internal or external)

Traceable to SI or national metrology institute

Traceable to pharmacopeial authority

Calibrated against certified or pharmacopeial standard

Certificate of Analysis (CoA)

Detailed CoA with purity, method, lot info

Extensive CoA with uncertainty, homogeneity, stability data

Monograph-aligned CoA or ID sheet

Internal CoA or assay report

Measurement Uncertainty

Not always specified

Yes (quantified)

Not quantified (implicit)

Not typically specified

Regulatory Acceptance

Accepted in general analytical labs

Globally accepted for ISO/IEC 17025, GMP, GLP

Required for pharmacopoeial compliance (e.g., FDA, EMA)

Internal lab use only

Usage Type

Quantitative/qualitative analysis

Primary standard for method validation

Reference standard for compendial tests

Secondary/backup standard

Primary Applications

Instrument calibration, method validation

Validation, accreditation, regulated testing

Drug substance/product testing, release assays

Routine QC tests, in-house calibration

Packaging

Solid, liquid, or ampoule; sealed packaging

Sealed ampoule, freeze-dried, or matrix-based

Controlled formats (neat or ampoule)

Flexible formats (bulk or small vials)


View all  Analytical Standard Grade products

目录: 阿拉丁试剂的规格、级别和纯度

Da — 若无特别说明,分子量单位默认为道尔顿。   Mw — 重均分子量。   Mn — 数均分子量。

产品仅供科研与开发使用,不用于人体、动物、诊断或治疗。

引用本文

阿拉丁科学.《Analytical Standard Grade》. 阿拉丁知识库,更新于 2025年7月23日。 https://www.aladdin-e.com/zh_cn/faqs/analytical-standard-grade-en.html
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