Protamine sulfate
- CAS Number
- 53597-25-4
- HSN Code
- 35040091
- Molecular Formula
- Basic protein mixture
- Catalogue Number
- AL02489
- Purity
- ≥ 90%
- Molecular Weight
- N/A g/mol
Complies with : IP | BP | USP | EP | ACS
ISO 9001
ISO 14001
GMP
COA with every batch
Key Properties
Protamine sulfate (purified) is a positively charged protein derived from herring, primarily used in medical applications as an anticoagulant reversal agent. It functions by binding to heparin, thereby neutralizing its anticoagulant effects, making it crucial in surgical settings where heparin is administered. Additionally, it serves as a stabilizer in insulin formulations, particularly in the preparation of NPH insulin, enhancing the stability and efficacy of the insulin product. Its unique properties as a protein make it a valuable compound in both pharmaceutical and biochemical research.
Also known as Protamine sulfate from herring.
- Catalogue No.
- AL02489
- CAS Number
- 53597-25-4
- Molecular Formula
- Basic protein mixture
- Molecular Weight
- N/A g/mol
- HSN Code
- 35040091
- Grade
- Purified
- Product Form
- Substance
Protamine sulfate appears as a white to off-white powder, which is hygroscopic in nature. It is soluble in water, allowing for easy incorporation into various formulations. The specific density of protamine sulfate is approximately 1.0 g/cm³, and it has a pH range of 6.0 to 7.5 when dissolved in water. The melting point is not specifically defined due to its protein nature, but it is stable under normal storage conditions. The compound is generally considered non-volatile and does not have a defined boiling point due to its protein structure.
- Appearance
- White to off-white powder
- Shelf Life
- -
- Packaging
- -
- Storage
- Store in a cool, dry place, away from direct sunlight.
1.1 — Product identifier
- Chemical Name
- Protamine sulfate
- Catalogue No.
- AL02489
- Product form
- Substance
- CAS Number
- 53597-25-4
- EC Number
- Not applicable
- Grade
- Purified
- EC Index Number
- Not applicable
- Chemical Formula
- Basic protein mixture
- HSN Code
- 35040091
- Synonyms
- Protamine sulfate from herring
1.2 — Relevant identified uses of the substance or mixture and uses advised against
- Use of the substance/mixture
- Anticoagulant reversal agent, insulin stabilizer
- 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
2.3 — Other hazards
- Other hazards
- None identified
3.1 — Substance
- Name
- Protamine sulfate
- CAS No.
- 53597-25-4
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
- Wash with soap and water. If irritation occurs, seek medical attention.
- First-aid measures after eye contact
- Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. If irritation persists, seek medical attention.
- First-aid measures after ingestion
- Rinse mouth. Do not induce vomiting. Seek medical attention if symptoms occur.
4.2 — Most important symptoms and effects, both acute and delayed
- Symptoms relating to use
- May cause allergic reactions in sensitive individuals.
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
- Non-flammable; however, combustion may produce toxic fumes.
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.
6.3 — Methods and material for containment and cleaning up
- Methods for cleaning up
- Use appropriate personal protective equipment and dispose of waste according to local regulations.
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 appropriate personal protective equipment.
- 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
- Store in a cool, dry place, away from incompatible materials.
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 of use.
9.1 — Information on basic physical and chemical properties
- Physical state
- Solid
- Colour
- White to off-white
- Odour
- Odourless
- Odour threshold
- Not applicable
- pH value
- 6.0 - 7.5
- Relative evaporation rate (butylacetate=1)
- Not applicable
- Melting point
- Not applicable
- Freezing point
- Not applicable
- Boiling point
- Not applicable
- Flash point
- Not applicable
- Auto-ignition temperature
- Not applicable
- Decomposition temperature
- Not applicable
- Flammability (solid, gas)
- Not flammable
- Vapour pressure
- Not applicable
- Relative vapour density at 20°C
- Not applicable
- Density
- ~1.0 g/cm³
- Solubility
- Soluble in water
- Log Pow
- Not applicable
- 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.
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
- Not specified
11.1 — Information on toxicological effects
- Acute toxicity
- Low toxicity; may cause allergic reactions in sensitive individuals.
- Skin corrosion/irritation
- May cause mild irritation in sensitive individuals.
- Serious eye damage/irritation
- May cause mild irritation.
- Respiratory or skin sensitisation
- May cause allergic skin reactions in sensitized individuals.
- Germ cell mutagenicity
- Not classified
- Carcinogenicity
- Not classified
- Specific target organ toxicity (single exposure)
- Not classified as a specific target organ toxicant.
- Specific target organ toxicity (repeated exposure)
- Not classified
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 applicable
- Proper Shipping Name (IMDG)
- Not applicable
- Proper Shipping Name (IATA)
- Not applicable
- Proper Shipping Name (ADN)
- Not applicable
- Proper Shipping Name (RID)
- Not applicable
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
Protamine sulfate is primarily utilized in the medical field as a heparin antagonist, effectively reversing the effects of heparin during surgeries or in cases of heparin overdose. It is also employed in the formulation of insulin, particularly in the development of NPH insulin, where it acts as a stabilizer to prolong the action of insulin in the body. Beyond its pharmaceutical applications, protamine sulfate is used in biochemical research for various assays and studies involving protein interactions and drug formulations. Its role in stabilizing other proteins and compounds makes it a versatile agent in both clinical and laboratory settings.
ISO 9001
ISO 14001
GMP
COA with every batch
- Batch Number
- AL-2026-AL02489
- Manufacturing Date
- September-2026
- Expiry Date
- September-2031
- Molecular Weight
- N/A g/mol
| Test | Standard | Observed |
|---|---|---|
| Assay | ≥ 90% | 92% |
| Moisture content | ≤ 5% | 3.2% |
| Residue on ignition | ≤ 1% | 0.5% |
| Related substances | None detected | None detected |
| Solubility | Soluble in water | Fully soluble |
The above product is expected to comply with Purified grade specification.
Technical Data Sheet
| Grade | Assay/Purity | Melting/Boiling Point | Moisture/LOD | Residue on Ignition | Related Substances | Solubility |
|---|---|---|---|---|---|---|
| Purified | ≥ 90% | Not applicable | ≤ 5% | ≤ 1% | None detected | Soluble in water |
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