Ramipril BP Ph Eur USP Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Ramipril BP Ph Eur USP Grade, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy Portugal, Bangladesh, etc. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Ramipril CAS Number 87333-19-5, EINECS EC Number: 642-904-3 or 1312995-182-4, Molecular Formula: C23H32N2O5, Molecular Weight: 416.52, HS Code 29339900 or 30049090
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SDS MSDS Sheet of Ramipril Manufacturers
Ramipril
BP Ph Eur USP Grade Suppliers
Ramipril is an ACE inhibitor type medication used to treat high blood pressure, heart failure, and diabetic kidney disease.
General Properties and Specifications of Ramipril:
Appearance: White to almost white powder or crystals.
Assay: >98%
Melting Point: 109C literature.
Solubility: Soluble in methanol.
Storage: Refrigerated (0-10C). Heat Sensitive.
Ramipril BP Ph Eur Grade Specifications:
C23H32N2O5 --- 416.5 CAS 87333-19-5
Action and use: Angiotensin converting enzyme inhibitor.
DEFINITION
(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid.
Content: 98.0 per cent to 101.0 per cent (dried substance).
CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Sparingly soluble in water, freely soluble in methanol.
IDENTIFICATION
A. Specific optical rotation.
B. Infrared absorption spectrophotometry.
TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 0.1 g in methanol and dilute to 10 mL with the same solvent.
Specific optical rotation: + 32.0 to + 38.0 (dried substance).
Related substances: To pass the test by Liquid chromatography.
Palladium: Maximum 20 ppm.
Loss on drying: Maximum 0.2 per cent, determined on 1.000 g by drying in an oven under high vacuum at 60C for 4 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Storage: Protected from light.
Ramipril USP Grade Specifications:
C23H32N2O5 --- 416.51
Cyclopenta[b]pyrrole-2-carboxylic acid, 1-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]octahydro-, [2S -[1[R*(R*)],2α,3aβ,6aβ]]-;
(2S ,3aS ,6aS )-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid, 1-ethyl ester
CAS 87333-19-5 ].
UNII: L35JN3I7SJ
DEFINITION
Ramipril contains NLT 98.0% and NMT 102.0% of ramipril (C23H32N2O5 ), calculated on the dried basis.
IDENTIFICATION
A. Infrared Absorption
B: The retention time of the major peak of the Sample solution corresponds to that of the Standard solution.
Residue on Ignition: NMT 0.1%
Limit of Palladium: To pass the test by atomic absorption spectrophotometry. --- 20 ppm.
Organic Impurities: To pass the test by chromatography.
Optical Rotation, Specific Rotation:
Sample solution: 10 mg/mL, in 0.1 M methanolic hydrochloric acid
Acceptance criteria: +32.0° to +38.0°, at 20°
Loss on Drying: Dry under vacuum at a pressure not exceeding 5 mm of mercury at 60C for 6 h. Acceptance criteria: NMT 0.2%
Packaging and Storage: Preserve in tight containers.
We manufacture Ramipril BP Ph Eur Grade.
For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.
We also manufacture and supply as under:
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Last
30 August, 2024
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Ramipril SDS, Safety Data Sheet
MSDS Sheet, Material safety Data Sheet 30-Aug-24
1. Product Identification
Product Name & Other Names: Ramipril.
CAS No.: 87333-19-5
EINECS: EC Number: 642-904-3 or 1312995-182-4
Molecular Weight: 416.52
Chemical Formula: C23H32N2O5
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Reproductive toxicity Category 1B, (H360)
Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements  Health Hazard |
Signal word: Danger.
Hazard statements:
H360 May damage fertility. May damage the unborn child.
Precautionary statements:
P210: Keep away from heat/sparks/open flames/hot surfaces – No smoking.
P261 Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P264: Wash … thoroughly after handling.
P270: Do not eat, drink, or smoke when using this product.
P280 Wear protective gloves/ eye protection/ face protection.
P305+ P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P308+313: IF exposed or concerned: Get medical advice/attention.
P501: Dispose of contents/container to an authorized agent only.
Classification according to Directive 67/548/EEC or Directive 1999/45/EC:
Hazard Symbol:
Xn = Harmful.
Risk Phrases:
R61: May cause harm to the unborn child.
R62: Possible risk of impaired fertility.
3. Composition/Information on Ingredients
Product Name & Other Names: Ramipril.
CAS No.: 87333-19-5
EINECS: EC Number: 642-904-3 or 1312995-182-4
Molecular Weight: 416.52
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
Note to Physician: Symptomatic and supportive treatment is recommended.
5. Fire Fighting Measures
Flammability of the Product: It is an organic material. Forms explosive mixtures with air on intense heating.
Products of Combustion: It emits Carbon oxides, Nitrogen oxides and fumes when heated.
Fire Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, or carbon dioxide.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Small Spill: Eliminate all sources of ignition. Avoid dust-mist formation. Avoid breathing dust. Ensure adequate ventilation. Use appropriate tools to put the spilled material in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and disposing of it according to local and regional authority requirements. Beware of vapors accumulating to form explosive concentrations. Vapors can accumulate in low areas.
Large Spill: Eliminate all sources of ignition. Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: Refrigerated (0-10C). Heat Sensitive.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: White to almost white powder or crystals.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: 109C literature.
Melting Point: 23C-25C literature.
Flash Point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in methanol.
Viscosity: Not available.
Molecular Weight: 416.52
Chemical Formula: C23H32N2O5
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage. Hygroscopic, Air sensitive, Light sensitive. Forms explosive mixtures with air on intense heating.
Hazardous Decomposition Products: It emits Carbon oxides, Nitrogen oxides and fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents, Heat.
Conditions to Avoid: Heat, Incompatibles.
11. Toxicological Information
Toxicity to Animals:
ORAL (LD50): >10000 mg/kg (Rat).
Carcinogenic Effects: Not a reported carcinogen.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Damage to fetus possible(N-methyl-2-pyrrolidone).
12. Ecological Information
BOD5 and COD: Not available.
Environmental Toxicity: Not available.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused contents in accordance with federal, state, and local requirements.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMDG/IMO: Not regulated.
IATA: Not regulated.
15. Regulatory Information
USA:
SARA 311/312 Hazards: Immediate (Acute) Health Hazard. See section 2.
California Prop. 65 Components: This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.
16. Other Information
European Labeling in Accordance with EC Directives:
H360 May damage fertility. May damage the unborn child.
Classification according to Directive 67/548/EEC or Directive 1999/45/EC:
Hazard Symbol:
Xn = Harmful.
Risk Phrases:
R61: May cause harm to the unborn child.
R62: Possible risk of impaired fertility.
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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