Regulatory Differences Between API and Intermediate Manufacturing: A Practical Guide
Regulatory differences between API and intermediate manufacturing under ICH Q7, FDA, EMA, and NMPA. GMP boundaries, DMF filing, starting material justification.
2-(2-AMINOTHIAZOL-4-YL)ACETICACIDHCL,2-(2-aminothiazol-4-yl)aceticacid, hydrochloide; ATA HYDROCHLORIDE
CAS:66659-20-9
Chemical Formula:C5H7ClN2O2S
MW:194.64
Availability: R&D; Commercialization
⬤ CAS No.66659-20-9
⬤ Packaging type:
20kg barrel;5kg barrel;1kg bag;500g bag ; Customized Packaging
| English name | 2-(2-Aminothiazol-4-yl) acetic acid hydrochloride |
| CAS No. | 66659-20-9 |
| Chemical formula | C5H7ClN2O2S |
| Molecular weight | 194.64 |
| Related categories | Pharmaceutical intermediates; Chemical raw materials;Intermediates; Raw materials; Chemical raw materials; Impurity reference substances; Organic acids; (intermediate of cefotiam); Pharmaceutical raw materials; Pharmaceutical raw material intermediates |
| Mol | 66659-20-9.mol |
| EINECS | 1308068-626-2 |
| Melting point | 152°C |
| Storage conditions | under inert gas (nitrogen or Argon) at 2-8°C |
| Solubility | Slightly soluble in methanol |
| form | solid |
| color | White to off-white |
| CAS | 66659-20-9 |
| Customs Tariff Code | 2934100090 |
| RTECS Number | YQ1509000 |
| GHS Hazard Pictograms | GHS07 |
| Signal Word | Warning |
| Hazard Statements | H315 (Causes skin irritation), H319 (Causes serious eye irritation), H335 (May cause respiratory irritation) |
| Physical State | White to off-white crystalline powder |
| Storage Conditions | Inert atmosphere, 2-8°C (In an inert gas environment, at 2-8°C) |
| Solubility | Slightly soluble in methanol |
| Precautionary Statements | It is recommended to avoid inhaling dust, wear protective respirators, and take appropriate first aid measures immediately if accidentally inhaled or contact with eyes. |
| Storage conditions | Should be stored in a dry, well-ventilated place, away from direct sunlight and high temperatures. |
| Use |
1. Mainly used as organic raw materials and pharmaceutical intermediates. 2. Used in the synthesis of antibiotics such as cefotiam. 3. Plays an important role in chemical synthesis and drug development. |
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Regulatory differences between API and intermediate manufacturing under ICH Q7, FDA, EMA, and NMPA. GMP boundaries, DMF filing, starting material justification.
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