Shandong Huashang Chemical Co., Ltd. is a high-tech enterprise focused on industry of fine chemicals research and develop, produce and sale. Shandong Huashang Chemical Co., Ltd. is located in Shan Dong Ji Nan China. we have the ability to provide you high quality products. More than 90 % of our products are exported to developed countries and regions such as north America, Europe, Japan, South Korea and the Middle East.
Diltiazem Hydrochloride
1. Basic Information
Name: Diltiazem hydrochloride
Alias: (2S,3S)-3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-2,3-dihydro-1,5-benzothiazepin-4(5H)-one hydrochloride
CAS No.: 33286-22-5
Molecular Formula: C??H??ClN?O?S
Molecular Weight: 466.98
Category: Calcium channel blocker cardiovascular API, anti-angina, antihypertensive raw material, antiarrhythmic pharmaceutical intermediate
2. Physical and Chemical Properties
Physical Properties
- Appearance: White or off-white crystalline powder
- Odor: Odorless, slightly bitter taste
- Solubility: Freely soluble in water, methanol, dilute acid; soluble in ethanol; slightly soluble in acetone; insoluble in ether, benzene, alkane solvents
- Melting Point: 210–215 ℃ (decomposes)
- Density (predicted): 1.34 g/cm3
- Hygroscopy: Slightly hygroscopic under high humidity
- Aqueous property: Aqueous solution weak acidic, pH 4.0–5.5; ester group prone to hydrolysis under strong alkali and heating
Chemical Properties
- Molecular structure: Benzothiazepine chiral skeleton, contains acetyl ester, dimethylamino, methoxy, sulfur heterocycle; chiral carbon determines pharmacological activity
- Pharmacological mechanism: Blocks L-type calcium channels of vascular smooth muscle and myocardium, dilates coronary vessels, reduces peripheral vascular resistance, lowers heart rate and blood pressure
- Ester hydrolysis: Acetoxy group hydrolyzes under alkaline/high temperature to form desacetyl diltiazem impurity, significantly reduces efficacy
- Oxidation sensitivity: Sulfur atom on benzothiazepine ring oxidizes under light and heavy metal ions to generate sulfoxide impurities
- Thermal stability: Stable below 70 ℃; long-term heating above 100 ℃ accelerates hydrolysis and oxidation degradation
- Photostability: Light-sensitive; UV irradiation turns powder yellow, related substances increase sharply
- Compatibility: Compatible with weak acidic buffer, mannitol, lactose excipients; incompatible with strong alkali, oxidants, iron/copper heavy metal salts
3. Main Application Fields
1. Cardiovascular Oral & Injection API (Core Application)
Raw material for tablets, sustained-release capsules, injections; clinically used for stable angina pectoris, hypertension, paroxysmal supraventricular tachycardia
2. Compound Cardiovascular Preparation Raw Material
Combined with statins, antiplatelet drugs to treat combined hypertension and coronary heart disease
3. Pharmacology Research Reagent
Calcium channel blocking positive control compound for cardiovascular cell drug screening
4. Quality Specification Table
| Test Item | Standard Specification |
| CAS Number | 33286-22-5 |
| Molecular Formula | C??H??ClN?O?S |
| Appearance | Uniform white crystal without yellow discoloration |
| HPLC Purity | Pharma API Grade ≥99.0% |
| Water Content (KF) | ≤0.50% |
| Residue on Ignition | ≤0.10% |
| Single Maximum Impurity | ≤0.10% |
| Total Related Substances | ≤0.50% |
| Chiral Isomer Impurity | ≤0.05% |
| Heavy Metals (Pb) | ≤10 ppm |
| Microbial Limit | Raw material meets oral pharmaceutical microbial standards, no pathogenic bacteria |
| Packaging | Nitrogen-filled amber light-proof aluminum foil vacuum bag; bulk 1kg/5kg PE lined light-proof fiber drum |
| Storage Condition | Hermetically sealed cool warehouse 2–25 ℃, full light shielding, isolate alkaline raw materials and metal ion additives |
| Transportation Requirement | Light-sensitive slightly hygroscopic cardiovascular API, sealed moisture-proof light-blocking packaging, separate from food and veterinary drugs |
| Shelf Life | 36 months under nitrogen vacuum sealed storage |
...
Product
