Nitroglycerine is a nitrate that dilates (widens) blood vessels.

Nitroglycerine rectal is used to treat moderate to severe pain caused by chronic anal fissures (tears in the skin lining your rectum).

Nitroglycerine rectal may also be used for purposes not listed in this medication guide.

 

Certificate of Analysis

• Description

  White, Odourless powder.

  Result

  White, Odourless powder.

• Identification by TLC

  The RF value of the principal spot of sample solution A correspond to that of the standard solution as obtained in the organic impurity test.

  Result

  Complies.

• Identification by HPLC

  The retention time of the sample solution correspond to that of the standard solution, as obtained in the assay.

  Result

  Complies.

• Assay by HPLC (% w/w)

  NLT 9.0 & NMT 11.0

  Result

  9.85

• Organic Impurity By TLC (%)

  The sum of the intensities of the secondary spots obtained in the test solution is NMT 3.

  Result

  Complies.

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Material Safety Data Sheet

• Section 1 – Chemical Product

  Product Identifier

  Nitroglycerine

  MSDS Prepared By

  R&D Department

• Section 2 – Composition / Information Of Ingredients

  Product Name

  Nitroglycerine

  Synonym

  Diluted Glyceryl Trinitrate

  Molecular Formula

  C3H5N3O9

  Molecular Weight

  354.19

  CAS Number

  55-63-0

• Section 3 – HAZARDOUS IDENTIFICATION

  Fire & Explosion

  This product is expected to be non-hazardous and non-combustible at room temperature.

  Adverse Effects

  Adverse effects of nitroglycerine may include sweet burning taste, dizziness, flushed face, rapid heartbeat, nausea or vomiting, throbbing headache, and restlessness. The estimated adult oral lethal dose of nitroglycerine is 200 mg to 1200 mg. Possible allergic reaction to material if inhaled, ingested or in contact with skin.

  Overdose Effects

  Overdose effects of nitroglycerine may include bluish-coloured lips, fingernails or palms; dizziness or fainting; pressure in head; blurred vision; shortness of breath; delirium; unusual tiredness or weakness; change in pulse; fever; convulsions; and possible death.

  Acute

  Eye, skin, gastrointestinal and/or respiratory tract irritation.

  Chronic

  Possible hypersensitization, severe headache, hallucinations, skin rash, and tolerance or dependence resulting in chest pain, heart attack, or death.

  Medical Conditions Aggravated by Exposure

  Hypersensitivity to material, active alcoholism, treatment with vasodilators, severe anaemia, hypothermia, cerebral haemorrhage or recent head trauma, glaucoma, severely impaired liver or kidney function, hyperthyroidism, hypertrophic cardiomyopathy, hypotension, and recent heart attack.

  Cross Sensitivity

  Rarely, persons sensitive to other nitrates or nitrites may be sensitive to this material also.

  Target Organs

  Cardiovascular system.

• Section 4 – FIRST AID

  Eye Contact

  Causes irritation. Avoid contact. Flush with copious quantities of tepid water for 15 minutes.

  Skin Contact

  Causes irritation and possible contact dermatitis. Avoid contact. Flush with copious quantities of soap and water. This material is readily absorbed through intact skin and can cause toxic effects.

  Inhalation

  May cause irritation and other toxic effects. Avoid inhalation. Remove to fresh air. nitroglycerine is absorbed through the lungs.

  Ingestion

  Causes irritation and may cause toxic effects and sweet burning taste. Avoid contact. Flush out mouth with water. This material is absorbed from the gastrointestinal tract, but nitroglycerine is more potent and much more readily absorbed from the mouth or tongue than when swallowed. It has a rapid onset and fairly brief duration of action.

  General First Aid Procedures

  Remove from exposure. Remove contaminated clothing. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If person is not breathing give artificial respiration. If breathing is difficult give oxygen. Obtain medical attention.

  Note to Physicians

  Overdose Treatment

  Treatment of nitroglycerine overdose should be symptomatic and supportive and may include the following: 1. Administer activated charcoal as a slurry. The benefit of activated charcoal following a large oral ingestion is unknown. / 2. For hypotension, infuse with isotonic fluid. If hypotension persists, administer dopamine or norepinephrine. / 3. For methemoglobinemia, slowly administer intravenous methylene blue in symptomatic patients. Additional doses may be required.

• Section 5 – FIRE FIGHTING MEASURES

  Extinguishing Media

  Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.

  Fire-fighting Procedures

  As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

• Section 6 – ACCIDENT RELEASE MEASURES

  Spill Response

  Shut off all ignition sources. Wear approved respiratory protection, chemically compatible gloves and protective clothing. Take up spillage with non- combustible absorbent material and place in closed, appropriately-labelled container for disposal. Wash spill site.

• Section 7 – HANDLING AND STORAGE

  Handling

  As a general rule, avoid all contact and inhalation of dust, mists, and/or vapours associated with the material. Wash thoroughly after handling.

  Storage

  Store in tight, light-resistant container. This material should be handled and stored per label instructions to ensure product integrity. Avoid exposure to excessive heat.

• Section 8 – EXPOSURE CONTROLS / PERSONAL PROTECTION

  Engineering Controls

  Engineering controls such as exhaust ventilation are recommended.

  Respiratory Protection

  Use a NIOSH approved respirator, if it is determined to be necessary by an industrial hygiene survey involving air monitoring.

  Gloves

  Chemically compatible.

  Eye Protection

  Safety glasses or goggles.

  Protective Clothing

  Protect exposed skin.

  Exposure Limits

  OSHA

  CEIL 0.2 ppm (skin); STEL 0.1 mg/m3 (skin)

  NIOSH

  STEL 0.1 mg/m3 (skin); IDLH 75 mg/m3

  ACGIH

  TWA 0.05 ppm (skin)

• Section 9 – PHYSICAL AND CHEMICAL PROPERITIES

  Appearance and Odour

  White odourless powder

  Odour Threshold

  N/A

  pH

  N/A

  Melting Range

  165°C (lactose); 13.5°C (nitroglycerine)

  Boiling Point

  50°C (nitroglycerine)

  Flash Point

  N/A

  Autoignition Temperature

  270°C (nitroglycerine)

  Evaporation Rate

  N/A

  Upper / Lower Flammability

  N/A

  Vapor Pressure

  N/A

  Vapour Density

  N/A

  Specific Gravity

  N/A

  Solubility in Water

  Soluble (lactose); slightly soluble (nitroglycerine)

  Fat Solubility

  N/A

  Other Solubility

  Soluble in methanol, in alcohol, in carbon disulphide, in acetone, in ethyl ether, in ethyl acetate, in glacial acetic acid, in benzene, in toluene, in nitrobenzene, in phenol, in chloroform, and in methylene chloride; sparingly soluble in petroleum ether, in liquid petroleum, and in glycerol

  Partition Coefficient

  n-octanol

  Water

  N/A

  Percent Volatile

  N/A

  Reactivity in Water

  N/A

  Explosive Properties

  N/A

  Oxidizing Properties

  N/A

• Section 10 – STABILITY AND REACTIVITY

  Conditions to Avoid

  Avoid exposure to light, heat, moisture, sparks, or flame.

  Incompatibilities

  Water, acids, strong alkalis, plastics and oxidizing materials.

  Decomposition Products

  When heated to decomposition material emits acrid smoke and toxic fumes of NOx. Emits toxic fumes under fire conditions.

  Hazardous Polymerization

  No

• Section 11 – TOXICOLOGICAL INFORMATION

  Oral Rat

  LD50: 105 mg/kg (nitroglycerine); Greater then 10 grams/kg (lactose)

  Oral Mouse

  LD50: 115 mg/kg (nitroglycerine)

  Other Toxicity Data

  Oral Guinea Pig

  LD50: 1450 mg/kg (nitroglycerine);

  Skin Rabbit

  LD50: >280 mg/kg (nitroglycerine)

  Irritancy Data

  N/A

  Corrosivity

  N/A

  Sensitization Data

  N/A

  Listed as a Carcinogen by

  NTP

  No

  IARC

  No

  OSHA

  No

  Other Carcinogenicity Data

  Rats receiving up to 434 mg/kg/day of dietary nitroglycerine for 2 years developed dose-related fibrotic and neoplastic changes in the liver, including carcinomas, and interstitial cell tumour in the testes. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerine was not tumorigenic in mice.

  Mutagenicity Data

  Nitroglycerine was weakly mutagenic in the Ames test in S. typhimurium, with or without activation. There was no evidence of mutagenicity in the in vivo dominant lethal assay in male rats treated with doses up to about 363 mg/kg/day or in the in vitro cytogenic tests in rat and dog tissues.

  Reproductive and Developmental Effects

  In a 3-generation reproduction study, rats received dietary nitroglycerine at doses up to about 434 mg/kg/day for 6 months prior to the mating of the F0 generation, with treatment continuing through successive F1 and F2 generations. Infertility was observed in the F1and F2 generations, and high doses were associated with decreased body weight in both sexes in all mattings. There was no clear evidence of birth defects in this study. No toxic effects on foetuses were observed in studies of rats and rabbits receiving 80 mg/kg/day or 250 mg/kg/day, respectively, of topically applied nitroglycerine ointment.

• Section 12 – ECOLOGICAL INFORMATION

  Freshwater Fish

  LC50 (96 hr): 1.38 mg/L (flow-through)

  Daphnia magna

  EC50 (48 hr): 46 mg/L

• Section 13 – DISPOSAL CONSIDERATION

  Disposal

  Dispose of waste in accordance with all applicable Federal, State and local laws.

• Section 14 – TRANSPORT INFORMATION

  Shipping Name

  Diluted Nitroglycerine

  UN No

  3319

  Class

  4.1

  Packing Group

  II

• Section 15 – REGULATORY INFORMATION

  General Information

  The information is an overview of major regulatory requirements. It should not be considered to be an exhaustive summary. Local Regulations should be consulted for additional requirements.

  U.S. Regulatory Information

  CERCLA/SARA Reportable Quantities

  4.54 kg (10 lb)

  International Regulatory Information

  EINECS # 200-559-2 (lactose); 200-240-8 (nitroglycerine)

  Hazard Code

  E, T+, N

  Risk Phrases

  R3, R26/27/28, R33, R51/53

  Safety Phrases

  S33, S35, S36/37, S45, S61

• Section 16 – OTHER INFORMATION

  Global Pharma provides information contained herein in good faith but makes no representation as to its comprehensives or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product.

  Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.

  GLOBAL PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OR MERCHANTABILITY, FITNESS FOR A PARTICULER PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE PRODUCT WHICH THE INFORMATION REEFERS. GLOBAL PHARMA WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF RELIANCE UPON THIS INFORMATION.