SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGP roduct IdentifierMaterial Name: Nitroglycerin Tablets ( , and mg)Trade Name:NITROSTAT; VERNIESC hemical Family:MixtureRelevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use:Pharmaceutical product for the treatment of angina pectorisDetails of the Supplier of the SAFETY data Sheet2. HAZARDS IDENTIFICATIONC lassification of the Substance or MixtureGHS - ClassificationAcute Oral Toxicity: Category 4 Acute Toxicity - Dusts and Mists: Category 4 Specific target organ systemic toxicity (repeated exposure): Category 2 Label ElementsSignal Word:WarningHazard Statements:H304 - May be fatal if swallowed and enters airwaysH332 - Harmful if inhaledH373 - May cause damage to organs through prolonged or repeated exposure: cardiovascularPrecautionary Statements:P260 - Do not breathe dust/fume/gas/mist/vapors/sprayP264 - Wash hands thoroughly after handlingP270 - Do not eat, drink or smoke when using this productP271 - Use only outdoors or in a well-ventilated areaP304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a positioncomfortable for breathingP301+ P312 - IF SWALLOWED.

2 Call a POISON CENTRE or doctor/physician if you feelunwellP312 - Call a POISON CENTRE/doctor/physician if you feel unwellP501 - Dispose of contents/container in accordance with all local and national regulations_____PD027 Pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Revision date: 28-Mar-2016 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Version: SAFETY data SHEETPage 1 of 10 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-800-879-3477 SAFETY data SHEET_____Other HazardsNo data availableNote:This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all needs may vary depending upon the potential for exposure in your COMPOSITION / INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEUEINECS/ELINCSListGHS Classification%Nitroglycerin55-63-0200-2 40-8 Acute Tox.

3 2 (H300)Acute Tox. 2 (H310)STOT RE 2 (H373)Aquatic Chronic 2 (H411)Acute Tox. 2 (H330)Unst. Expl. (H200) - monostearate31566-31-1250-705-4 Not Listed*Silicon dioxide, colloidal NF7631-86-9231-545-4 Not Listed*Calcium stearate1592-23-0216-472-8 Not Listed*Starch, pregelatinized9005-25-8232-679-6 Not Listed*IngredientCAS NumberEUEINECS/ELINCSListGHS Classification%Lactose NF, monohydrate64044-51-5 Not ListedNot Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety. In accordance with 29 CFR , the exact percentage composition of thismixture has been withheld as a trade the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 164. FIRST AID MEASURESD escription of First Aid MeasuresEye Contact:Flush with water while holding eyelids open for at least 15 minutes. Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water.

4 Use soap. Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention : 2 of 10 Revision date: 28-Mar-2016 Material Name: Nitroglycerin Tablets ( , and mg) SAFETY data SHEET_____Inhalation:Remove to fresh air and keep patient at rest. Seek medical attention Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological ConditionsAggravated by Exposure:None knownIndication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician:None5. FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Hazards Arising from the Substance or MixtureHazardous CombustionProducts:Formation of toxic gases is possible during heating or / Explosion Hazards:Not applicableAdvice for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing ACCIDENTAL RELEASE MEASURESP ersonal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8).

5 Minimize PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area Consideration forLarge Spills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained HANDLING AND STORAGEP recautions for Safe HandlingMinimize dust generation and accumulation. If tablets or capsules are crushed and/or broken, avoid breathing dust and avoidcontact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Washthoroughly after handling.

6 Releases to the environment should be avoided. Review and implement appropriate technical andprocedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potentialpoints of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systemsor other equivalent for Safe Storage, Including any IncompatibilitiesStorage Conditions:Store as directed by product end use(s):Pharmaceutical product8. EXPOSURE CONTROLS / PERSONAL PROTECTIONC ontrol Parameters_____PD027 Revision date: 28-Mar-2016 Material Name: Nitroglycerin Tablets ( , and mg)Version: 3 of 10 SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure mg/m3 Germany - Biological Exposure g/LAustralia mg/m3 Greece OEL - ppm2 mg/m3 Hungary OEL - mg/m3 Austria OEL - MAKsIreland OEL - mg/m3 Japan - OELs - mg/m3 NitroglycerinLithuania OEL - mg/m3 Belgium OEL - mg/m3 OSHA - Final PELs - Skin Notations:prevent or reduce skin absorptionRevision date: 28-Mar-2016 Poland OEL - mg/m3 Material Name: Nitroglycerin Tablets ( , and mg)Portugal OEL - ppmCzech Republic OEL - mg/m3 Romania OEL - mg/m3 ACGIH Threshold Limit Value (TWA)Slovakia OEL - mg/m3 Estonia OEL - TWAS lovenia OEL - ppmSpain OEL - mg/m3 Sweden OEL - mg/m3 Finland OEL - mg/m3 Switzerland OEL mg/m3 Version: - Biological Exposure Limit.

7 15 mol/mol creatinineVietnam OEL - mg/m3 France OEL - ppm1 mg/m3 Glyceryl monostearateACGIH - Skin Absorption DesignationSkin - potential significant contribution to overall exposure by thecutaneous routeACGIH Threshold Limit Value (TWA)10 mg/m3 Germany - TRGS 900 - mg/m3 Page 4 of 10 Germany (DFG) - MAK SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONE xposure ControlsEngineering Controls:Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this ProtectiveEquipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).Hands:Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing :Wear SAFETY glasses or goggles if eye contact is Threshold Limit Value (TWA)10 mg/m3 Lithuania OEL - TWAL ithuania OEL - TWA5 mg/m3 Czech Republic OEL - mg/m3 Sweden OEL - TWAs5 mg/m35 mg/m3 Starch, pregelatinizedACGIH Threshold Limit Value (TWA)10 mg/m3 Estonia OEL - TWA2 mg/m3 Australia TWA10 mg/m3 Belgium OEL - TWA10 mg/m3 Finland OEL - TWAB ulgaria OEL - mg/m35 mg/m3 Czech Republic OEL - mg/m3 Sweden OEL - TWAs5 mg/m3 Greece OEL - TWA10 mg/m35 mg/m3 Germany - TRGS 900 - TWAs4 mg/m3 Ireland OEL - TWAs10 mg/m34 mg/m3 OSHA - Final PELS - TWAs:15 mg/m3 Revision date: 28-Mar-2016 Portugal OEL - TWA10 mg/m3 Germany (DFG) - MAK4 mg/m3 Slovakia OEL - TWA4 mg/m3 Silicon dioxide, colloidal NFSpain OEL - TWA10 mg/m3 Ireland OEL - TWAsSwitzerland OEL -TWAs3 mg/m36 mg/m3 Material Name.

8 Nitroglycerin Tablets ( , and mg)Latvia OEL - TWA1 mg/m3 OSHA - Final PELs - Table Z-3 Mineral D:20 mppcfListedAustralia TWA2 mg/m3 Slovakia OEL - mg/m3 Version: 5 of 10 Switzerland OEL -TWAs4 mg/m3 Austria OEL - MAKsCalcium stearate4 mg/m3 SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONSkin:Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the PHYSICAL AND CHEMICAL PROPERTIESS olvent Solubility:No data availableWater Solubility:No data availablepH:No data Point ( C):No data availableBoiling Point ( C):No data Coefficient: (Method, pH, Endpoint, Value)Decomposition Temperature ( C):No data Rate (Gram/s):No data availableVapor Pressure (kPa):No data availableVapor Density (g/ml):No data availableRelative Density:No data availableViscosity:No data availableFlammablity:Autoignition Temperature (Solid) ( C):No data availableFlammability (Solids):No data availableFlash Point (Liquid) ( C).

9 No data availableUpper Explosive Limits (Liquid) (% by Vol.):No data availableLower Explosive Limits (Liquid) (% by Vol.):No data availableThe active ingredient in this formulation is highlyexplosive. However, based on the amount of active ingredientcontained in this product it is not expected to pose an :Will not occur10. STABILITY AND REACTIVITYR eactivity:No data availableChemical Stability:Stable under normal conditions of of Hazardous Reactions_____PD027 Physical State:TabletLactose NF, monohydrateMaterial Name: Nitroglycerin Tablets ( , and mg)No data availableColor:WhiteNitroglycerinVersion : data availableOdor:No data dioxide, colloidal NFPage 6 of 10No data availableOdor Threshold:No data , pregelatinizedNo data availableMolecular Formula:MixtureCalcium stearateNo data availableMolecular Weight:MixtureGlyceryl monostearateRevision date: 28-Mar-2016No data available SAFETY data SHEET_____10. STABILITY AND REACTIVITYO xidizing Properties:No data availableConditions to Avoid:Avoid direct sunlight, conditions that might generate heat, and sources of Materials:As a precautionary measure, keep away from strong oxidizersHazardous DecompositionProducts:None known11.

10 TOXICOLOGICAL INFORMATIONI nformation on Toxicological EffectsGeneral Information:The information included in this section describes the potential hazards of the Term:May be absorbed through the skin and cause systemic effects. Chest pain, acute myocardialinfarction, and sudden death have occurred during temporary withdrawal of organic nitratesfrom industrial workers exposed for long periods of Clinical Effects:Headache, which may be severe and persistent, may occur immediately after use. Vertigo,dizziness, weakness, palpitation, and other manifestations of postural hypotension maydevelop occasionally. Flushing, drug rash, and exfoliative dermatitis have been reported inpatients receiving nitrate Toxicity: (Species, Route, End Point, Dose)Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))_____PD027 Embryo / Fetal Development Rabbit Oral 240 mg/kg/day NOAEL Not TeratogenicRabbit Dermal LD50 > 280mg/kgNitroglycerinRevision date.