Nifedipine
- CAS Number
- 21829-25-4
- HSN Code
- 29420013
- Molecular Formula
- C17H18N2O6
- Catalogue Number
- AL3241
- Purity
- ≥ 98%
- Molecular Weight
- 346.33 g/mol
Complies with : IP | BP | USP | EP | ACS
ISO 9001
ISO 14001
GMP
COA with every batch
Key Properties
Nifedipine is a methyl ester, a C-nitro compound and a dihydropyridine. It has a role as a vasodilator agent, a calcium channel blocker, a tocolytic agent and a human metabolite.
Also known as Nifedipine, 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid dimethyl ester.
- Catalogue No.
- AL3241
- CAS Number
- 21829-25-4
- Molecular Formula
- C17H18N2O6
- Molecular Weight
- 346.33 g/mol
- HSN Code
- 29420013
- Grade
- 98%
- Product Form
- Substance
Melting point: 172-174 °C.
- Appearance
- Yellow crystals
- Shelf Life
- 2 years
- Packaging
- Available in: 5 gm glass bottle, 25 gm glass bottle
- Storage
- Nifedipine liquid-filled capsules should be protected from light and moisture and stored in tight, light-resistant containers at a temperature of 15-25 °C, and extended-release tablets of the drug should be protected from light and moisture and stored in tight, light-resistant containers at a temperature less than 30 °C.
1.1 — Product identifier
- Chemical Name
- Nifedipine
- Catalogue No.
- AL3241
- Product form
- Substance
- CAS Number
- 21829-25-4
- EC Number
- 244-598-3
- Grade
- 98%
- EC Index Number
- 607-052-00-8
- Chemical Formula
- C17H18N2O6
- HSN Code
- 29420013
- Synonyms
- Nifedipine, 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid dimethyl ester
1.2 — Relevant identified uses of the substance or mixture and uses advised against
- Use of the substance/mixture
- Calcium channel blocker used in the treatment of hypertension and angina.
- Uses advised against
- Not specified
1.3 — Details of the supplier of the safety data sheet
- Company identification
- Address:- 102, B wing, Savgan Heights, RTO Lane,Andheri (W), Mumbai-400 053Maharashtra, India.
1.4 — Emergency Contact Details
- Phone / e-Mail
- Phone : +91 22 26317055 Mobile : +91 9820385757 e-mail : info@alphachemika.co.in
2.1 — Classification of the substance or mixture
- Classification according to Regulation (EC) No 1272/2008
- Acute Tox. 4
- Classification source
- ECHA C&L Inventory via PubChem CID 4485 - hazard classes notified by at least 50% of companies; pictograms and signal word derived from those statements
2.2 — Label elements
- Hazard pictograms
- Irritant
- Signal word
- Warning
- Hazard statements
- H302: Harmful if swallowed
2.3 — Other hazards
- Other hazards
- Light-sensitive; handle with care to avoid degradation.
3.1 — Substance
- Name
- Nifedipine
- CAS No.
- 21829-25-4
4.1 — Description of first aid measures
- First-aid measures after inhalation
- Move to fresh air. If symptoms persist, seek medical attention.
- First-aid measures after skin contact
- IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water.
- First-aid measures after eye contact
- First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center.
- First-aid measures after ingestion
- Rinse mouth. Do not induce vomiting. Seek medical attention immediately.
4.2 — Most important symptoms and effects, both acute and delayed
- Symptoms relating to use
- Headache, dizziness, flushing, and peripheral edema may occur.
4.3 — Indication of any immediate medical attention and special treatment needed
- General information
- Treat symptomatically. Show this safety data sheet to the treating physician.
5.1 — Extinguishing media
- Suitable extinguishing media
- Water spray, carbon dioxide, dry chemical powder, foam.
- Unsuitable extinguishing media
- Not specified
5.2 — Special hazards arising from the substance or mixture
- Special procedures
- May emit toxic fumes under fire conditions.
5.3 — Advice for firefighters
- Protection during firefighting
- Do not enter fire area without proper protective equipment, including respiratory protection.
6.1.1 — For non-emergency personnel
- Emergency procedures
- Contain spill and collect using appropriate protective equipment. Dispose of in accordance with local regulations.
6.3 — Methods and material for containment and cleaning up
- Methods for cleaning up
- Use appropriate personal protective equipment. Sweep up and place in a suitable container for disposal.
6.4 — Reference to other sections
- Reference
- Not specified
7.1 — Precautions for safe handling
- Precautions for safe handling
- Avoid contact with skin and eyes. Use gloves and protective eyewear.
- Hygiene measures
- Wash hands and other exposed areas with mild soap and water before eating, drinking or smoking and when leaving work.
7.2 — Conditions for safe storage, including any incompatibilities
- Storage conditions
- Nifedipine liquid-filled capsules should be protected from light and moisture and stored in tight, light-resistant containers at a temperature of 15-25 °C, and extended-release tablets of the drug should be protected from light and moisture and stored in tight, light-resistant containers at a temperature less than 30 °C.
8.2 — Exposure controls
- Hand protection
- Protective gloves (e.g. nitrile rubber)
- Eye protection
- Chemical safety goggles or safety glasses
- Skin and body protection
- Wear suitable protective clothing
- Respiratory protection
- Not required under normal conditions; use in a well-ventilated area.
9.1 — Information on basic physical and chemical properties
- Physical state
- Solid
- Colour
- Yellow
- Odour
- Odourless
- Odour threshold
- Not applicable
- pH value
- Not applicable
- Relative evaporation rate (butylacetate=1)
- Not applicable
- Melting point
- 172-174 °C
- Freezing point
- Not applicable
- Boiling point
- 420 °C
- Flash point
- Not applicable
- Auto-ignition temperature
- Not applicable
- Decomposition temperature
- Not applicable
- Flammability (solid, gas)
- Not flammable
- Vapour pressure
- 2.6X10-8 mm Hg at 25 °C
- Relative vapour density at 20°C
- Not applicable
- Density
- 1.3 g/cm³
- Solubility
- Practically insoluble in water; soluble in organic solvents like ethanol and methanol.
- Log Pow
- 2.20
- Viscosity, kinematic
- Not applicable
- Viscosity, dynamic
- Not applicable
- Explosive properties
- Not explosive
- Oxidising properties
- Not oxidizing
- Explosive limits
- Not applicable
10.1 — Reactivity
- Reactivity
- Stable under normal conditions; avoid light exposure.
10.2 — Chemical stability
- Chemical stability
- Stable under recommended storage conditions.
10.3 — Possibility of hazardous reactions
- Possibility of hazardous reactions
- No dangerous reactions known under normal conditions of use.
10.4 — Conditions to avoid
- Conditions to avoid
- Avoid contact with incompatible materials and excessive heat.
10.5 — Incompatible materials
- Incompatible materials
- Strong oxidizing agents.
10.6 — Hazardous decomposition products
- Hazardous decomposition products
- When heated to decomposition, it emits toxic fumes of nitrogen oxides.
11.1 — Information on toxicological effects
- Acute toxicity
- LD50 Rat oral 1022 mg/kg; LD50 Mouse oral 310 mg/kg; LD50 Rat ip 230 mg/kg
- Skin corrosion/irritation
- Not classified (based on available data)
- Serious eye damage/irritation
- Not classified (based on available data)
- Respiratory or skin sensitisation
- Not classified (based on available data)
- Germ cell mutagenicity
- Not classified (based on available data)
- Carcinogenicity
- Not classified (based on available data)
- Specific target organ toxicity (single exposure)
- Not classified (based on available data)
- Specific target organ toxicity (repeated exposure)
- Not classified (based on available data)
12.1 — Toxicity
- Toxicity information
- Not specified
12.2 — Persistence - degradability
- Persistence - degradability
- Not specified
12.3 — Bioaccumulative potential
- Bioaccumulative potential
- Not specified
12.4 — Mobility in soil
- Mobility in soil
- Not specified
12.6 — Other adverse effects
- Environmental precautions
- Not specified
13.1 — Waste treatment methods
- Additional Info
- Dispose of contents/container in accordance with local, regional, national and international regulations.
14.1 — UN number
- UN-No. (ADR)
- Not assigned
- UN-No. (IMDG)
- Not assigned
- UN-No. (IATA)
- Not assigned
- UN-No. (ADN)
- Not assigned
- UN-No. (RID)
- Not assigned
14.2 — UN proper shipping name
- Proper Shipping Name (ADR)
- Not classified as dangerous goods
- Proper Shipping Name (IMDG)
- Not classified as dangerous goods
- Proper Shipping Name (IATA)
- Not classified as dangerous goods
- Proper Shipping Name (ADN)
- Not classified as dangerous goods
- Proper Shipping Name (RID)
- Not classified as dangerous goods
14.3 — Transport hazard class(es)
- Transport hazard class(es)
- Not applicable
14.4 — Packing group
- Packing group (ADR)
- Not applicable
- Packing group (IMDG)
- Not applicable
- Packing group (IATA)
- Not applicable
- Packing group (ADN)
- Not applicable
- Packing group (RID)
- Not applicable
14.5 — Environmental hazards
- Dangerous for the environment
- Not specified
- Marine pollutant
- Not specified
- Other information
- No supplementary information available
15.1 — Safety, health and environmental regulations/legislation specific for the substance or mixture
- 15.1.1 EU-Regulations
- Not specified
Nifedipine is primarily used in the treatment of hypertension and angina. It serves as a reference standard in pharmaceutical quality control and cardiovascular drug research.
ISO 9001
ISO 14001
GMP
COA with every batch
- Batch Number
- AL-2026-AL02456
- Manufacturing Date
- September-2026
- Expiry Date
- September-2031
- Molecular Weight
- 346.33 g/mol
| Test | Standard | Observed |
|---|---|---|
| Assay | ≥ 98% | 99.5% |
| Melting Point | 170-172 °C | 171 °C |
| Moisture Content | ≤ 0.5% | 0.3% |
| Residue on Ignition | ≤ 0.1% | 0.05% |
| Related Substances | None detected | None detected |
| Solubility | Practically insoluble in water | Practically insoluble in water |
The above product is expected to comply with 98% grade specification.
Technical Data Sheet
| Grade | Assay/Purity | Melting/Boiling Point | Moisture/LOD | Residue on Ignition | Related Substances | Solubility |
|---|---|---|---|---|---|---|
| 98% | ≥ 98% | m.p. 172-174 °C | ≤ 0.5% | ≤ 0.1% | None detected | Practically insoluble in water |
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