Reaction mass of (1R,2S,5S)-N-{(1S)-1-cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl}-6,6-dimethyl-3-[3-methyl-N-(trifluoroacetyl)-L-valyl]-3-azabicyclo[3.1.0]hexane-2-carboxamide and tertbutyl methyl ether

Guidance on Safe Use

First-aid measures

Description of first aid measures  

Inhalation: Remove to fresh air. Seek immediate medical attention/advice.  

Eye contact: Rinse thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician.  

Skin contact: Remove contaminated clothing.  Flush area with large amounts of water.  Use soap.  Seek medical attention.  

Ingestion: Never give anything by mouth to an unconscious person.  Wash out mouth with water.  Do not induce vomiting unless directed by medical personnel.  Seek medical attention immediately.  

Fire-fighting measures

Extinguishing media  

Dry chemical, CO2, alcohol-resistant foam or water spray.  

Specific hazards arising from the chemical

Flammable solid. Fine particles (such as dust and mists) may fuel fires/explosions.  

Hazardous combustion products Formation of toxic gases is possible during heating or fire. May include oxides of carbon, nitrogen, phosphorous.  

Advice for firefighters  

Special protective equipment for fire-fighters: Firefighters should wear self-contained breathing apparatus and full firefighting turnout gear. Use personal protection equipment.  

Accidental release measures

Personal precautions, protective equipment and emergency procedures  

Personnel involved in clean-up should wear appropriate personal protective equipment (see

PPE listed beloe).  Minimize exposure.

For emergency responders: Use personal protection recommended in PPE section below.  

Environmental precautions: Place waste in an appropriately labeled, sealed container for disposal.  Care should be taken to avoid environmental release.  

Methods and material for containment and cleaning up:  

Prevent further leakage or spillage if safe to do so.  

Methods for cleaning up: Eliminate possible ignition sources (e.g., heat, sparks, flame, impact, friction, electricity), and follow appropriate grounding procedures. Contain the source of the spill if it is safe to do so. Collect spilled material by a method that controls dust generation. Avoid use of a filtered vacuum to clean spills of dry solids. Clean spill area thoroughly.

Prevention of secondary hazards Clean contaminated objects and areas thoroughly observing environmental regulations.    

Handling and storage

Precautions for safe handling :

Ground and bond all bulk transfer equipment. Avoid open handling. Minimize dust generation. Use local exhaust ventilation or perform work under fume hood/fume cupboard. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment (listed below). Wash hands and any exposed skin after removal of PPE. Releases to

the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases.  Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls.

General hygiene considerations Handle in accordance with good industrial hygiene and safety practice.  

Conditions for safe storage, including any incompatibilities  

Store at room temperature in properly labelled containers. Protect from light. Keep away from heat, sparks, and flames.  

 

Specific use(s)  Pharmaceutical active.  

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:

UN 3175

Shipping information

Proper shipping name and description:

Solids containing flammable liquid, n.o.s. (Tert-butyl methyl ether)

Class or division:

Class 4: Flammable solids, substances liable to spontaneous combustion, substances which, on contact with water, emit flammable gases; Division 4.1

Packing group:

Packing group II: Substances presenting medium danger

SpecialProvisions

Shipping

Remarks

Marine transport (UN RTDG/IMDG)

Shipping

Remarks

Shipping

Remarks

SpecialProvisions

Exposure controls / personal protection

Control parameters  

Exposure Limits: Refer to available public information for specific member state Occupational Exposure Limits.  

+ Tert-butyl methyl ether

ACGIH TLV 50 ppm

EU: 50 ppm (183.5 mg/m3); STEL: 100 ppm (367 mg/m3)

PF-07321332: Pfizer Occupational Exposure OEB 3 - Contact Hazards Unknown (control exposure to the range of 10ug/m3 to < 100ug/m3)

Pfizer OEB Statement:The purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categories when the available data are sufficient to do so,but inadequate to establish an Occupational Exposure Limit (OEL). The OEB given is based upon an analysis of all currently available data; as such, this value may be subject to revision when new information becomes available.  

Engineering controls: Engineering controls should be used as the primary means to control exposures.  Use process containment, local exhaust ventilation, or other engineering controls to maintain airborne levels to below the OEB range.  

Environmental exposure controls No information available.  

Personal protective equipment Contact your safety and health professional or safety equipment supplier for assistance in selecting the correct protective clothing/equipment based on an assessment of the workplace conditions, other chemicals used or present in the workplace and specific operational processes. Refer to applicable national standards and regulations in the

selection and use of personal protective equipment (PPE).  

Eye/face protection: Wear safety goggles as minimum protection.  (Eye protection must meet the standards in accordance with EN166, ANSI Z87.1 or international equivalent.).  

Hand protection: Wear 2 layers of impervious disposable gloves (e.g. Nitrile, etc.) to prevent skin contact.  (Protective gloves must meet the standards in accordance with EN374, ASTM F1001 or

international equivalent.).  

Skin and body protection : Wear impervious protective clothing to prevent skin contact – consider use of disposable clothing where appropriate.  (Protective clothing must meet the standards in accordance with EN13982, ANSI 103 or international equivalent.).  

Respiratory protection: Under normal conditions of use, if the applicable Occupational Exposure Band (OEB) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEB (e.g. particulate respirator with a full mask, P3 filter). (Respirators must meet the standards in accordance with EN136, EN143, ASTM F2704-10

or international equivalent.).  

General hygiene considerations Handle in accordance with good industrial hygiene and safety practice.  

Stability and reactivity

Reactivity: No data available.  

Stability: Stable under normal conditions.  

Sensitivity to Mechanical Impact: No data available.

Sensitivity to Static Discharge: No data available.  

Possibility of hazardous reactions: No information available.

Conditions to avoid: Heat, sparks, flame, and electrostatic discharge.  

Incompatible Materials: As a precautionary measure, keep away from strong oxidizers

Disposal considerations

Waste treatment methods  

Dispose of waste in accordance with all applicable laws and regulations.  Member State specific and Community specific provisions must be considered.  Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural wastewater and waste disposal measures to prevent occupational exposure and environmental release.  It is recommended that waste minimization be practiced.  The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater.