T/CGAPA 008-2023 Active Group standards

T/CGAPA 008-2023 L-DOPA Quality Requirements

Publish Date: 2023-01-12 Implement Date: 2023-01-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/CGAPA 008-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Terminology (principles and coordination and cooperation)

Publish Date: 2023-01-12

Implement Date: 2023-01-20

Scope

Scope: This document specifies the terms and definitions, technical requirements, inspection methods, inspection rules, packaging, labeling, transportation, storage, and shelf life requirements for levodopa. This document applies to levodopa obtained from Stizolobium cochinchinensis (Lour.) Tang et Wang seeds through extraction, separation, and purification. Main technical content: 4. Technical requirements 4.1 Process requirements 4.1.1 Plant raw materials: Use Stizolobium cochinchinensis (Lour.) Tang et Wang seeds as plant raw materials, harvested in autumn, with impurities removed and dried in the sun. 4.1.2 Raw material requirements: The raw materials shall comply with the requirements of GB 2763. 4.1.3 Process: Crush the raw materials, extract with water, remove impurities, decolorize, crystallize, and refine into a dried product. 4.1.4 Water requirements: The water shall comply with the requirements of GB/T 6682. 4.2 Product requirements 4.2.1 Sensory indicators: The sensory characteristics shall comply with the provisions of Table 1. Table 1: Sensory characteristics Item Characteristic Color White or off-white, with uniform color Texture Crystalline powder, loose and without clumping Odor No abnormal odor Impurities No visible impurities to the naked eye 4.2.2 Physicochemical indicators: The physicochemical indicators shall comply with the provisions of Table 2. Table 2: Physicochemical indicators Item Characteristic Identification The test samples shall have the experimental characteristics of the product Water content (%) ≤5.0 Ash content (%) ≤0.1 Levodopa content (as dry product) (%) ≥90.0 Specific rotation (°) -159° to -168° Melting point (°C) 276–278 (decomposition) Arsenic (As) (mg/kg) ≤0.1 Lead (Pb) (mg/kg) ≤0.5 4.2.3 Microbiological requirements: The microbiological requirements shall comply with the provisions of Table 3. Table 3: Microbiological indicators Item Indicator To