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Wuxi High Mountain Hi-tech Development Co.,Ltd 86-510-85881875 harold@high-mountain.cn
Sodium Chloroacetate White Crystalline Solid C2H2ClNaO2 for Laboratory Organic Reagent Use

Sodium Chloroacetate White Crystalline Solid C2H2ClNaO2 for Laboratory Organic Reagent Use

  • Highlight

    Astragalus Extract Total Saponins

    ,

    P.E. Astragalus Extract

  • Product Name
    Sodium Chloroacetate; SMCA;Chloroacetic Acid Sodium Salt
  • Purity
    97% Min.; 98% Min.; 99% Min.
  • Application
    Chemical Intermediates
  • EINECS
    223-498-3
  • Sample
    Avaliable
  • MOQ
    1mt
  • Packing
    500g, 1kg, 10kg, 100kg PP+PE BAGS
  • Storage
    Cool Dry Place
  • Place of Origin
    China
  • Brand Name
    HMHT
  • Certification
    ISO9001
  • Model Number
    HMHT0003
  • Minimum Order Quantity
    500 Kilogram / Kilograms
  • Price
    USD (60-100)/ Kilogram
  • Packaging Details
    25L/30L Plastic Drum
  • Delivery Time
    Within 3 Weeks
  • Payment Terms
    L/C, D/P, T/T, Western Union, MoneyGram
  • Supply Ability
    100 Metric Ton/Metric Tons per Year

Sodium Chloroacetate White Crystalline Solid C2H2ClNaO2 for Laboratory Organic Reagent Use

SMCA as an API Intermediate — Regulatory Context

Although SMCA itself is not a final drug, when used as an active pharmaceutical ingredient (API) intermediate, it falls under stringent regulatory oversight. Manufacturers must comply with Good Manufacturing Practice (GMP) standards according to FDA 21 CFR parts 210/211 and EU GMP guidelines published by EMAfda.gov.


2. Quality Dossier Preparation for SMCA in Drug Supply Chains

When supplying SMCA to pharmaceutical companies, providers must prepare a Chemistry, Manufacturing & Controls (CMC) dossier—often included in Module 3 of eCTD submissions.
FDA and EMA require validated test methods, impurity profiles, and process validation data, referencing ICH Q2 (analytical) and Q7 (API GMP) guidelines fda.govfda.gov.


3. Process Validation & Scale-Up Requirements

According to FDA and EMA, SMCA’s commercial manufacturing must follow a Stage‑wise process validation approach:

  • Stage 1: process design and scale-up establishment

  • Stage 2: process performance qualification (PPQ) with at least three consecutive compliant batches prior to marketing release fda.gov+1fda.gov+1.


4. Control of Impurities & Nitrosamines

While SMCA is not a nitrosamine, its use may introduce impurity risks. Manufacturers must demonstrate control strategies and impurity limits following FDA’s nitrosamine guidance, including risk assessment and acceptable intake (AI) protocols—mirroring API best practices fda.gov+3fda.gov+3ema.europa.eu+3.


5. Regulatory Engagement and Submissions

SMCA manufacturers supplying API intermediates may pursue Scientific Advice (EMA) or Pre-Submission meetings (FDA) to align strategies on quality, impurity control, and validation.
Early engagement helps reduce regulatory delays and ensures alignment with guidelines .


6. Packaging, Stability, and Supplier Qualifications

Regulators expect sterile-grade intermediates like SMCA to have validated packaging and storage, supported by stability data and ISO IDMP/PQ-CMC documentation structure fda.gov.
Supplier qualification under cGMP—covering raw materials, process changes, and audit records—is also mandatory.


7. Internal Link to HighMountainChem

If you're sourcing pharmaceutical-grade SMCA, HighMountainChem provides fully documented Sodium Chloroacetate (SMCA) suitable for API use, with full CMC support, CoAs, and technical data:
https://highmountainchem.com/sodium-chloroacetate-cas-3926-62-3/

 

Company Profile

 

Sodium Chloroacetate White Crystalline Solid C2H2ClNaO2 for Laboratory Organic Reagent Use 0

 

Wuxi High Mountain Hi-tech Development Co., Ltd is a professional industrial company engaged in special

chemical production, technology research & development, and import & export. The company focuses on 

the production, trade, and research & development of various chemical products.

Since establishment, the company has been concentrating on constructing an international marketing

network and optimizing supply chain management, where we have established a long-term strategic

cooperation relationship with numerous large enterprises at home and abroad. Relying on our wide business

channels and professional experience, we are more skillfully providing products of stable but differentiated

quality, along with flexible, highly efficient & considerate service to satisfy our partner at more competitive pricing.

 

Efficiently treating our customers as partners with sincerity, specialization and satisfaction is our managerial

principle. Attributed to the backup of a dedicated technical team, filled with wide and profound knowledge

and practice in chemicals and world trade for 20 years, the company owns rich experience in product quality

control, technical solution, chemical logistics organization, packaging optimization, port operation, etc., which

accounts for its first-class cost control management and ensures to maintain the overwhelming competitive

advantage over others. In line with the principle of sharing the preferential cost and joint development, the

company has formed an interesting community for years with its customers at home and abroad. Sincerely

to build up a pleasant mutual trust, cooperative, win-win, and value-added sustainable partnership is what

we are achieving to grow together with you!

 

Sodium Chloroacetate White Crystalline Solid C2H2ClNaO2 for Laboratory Organic Reagent Use 1