2-[(2S,3S)-3-[[(1,1dimethylethoxy)carbonyl]amino]-2-hydroxy-4-phenylbutyl]-2-[[4-(2pyridinyl)phenyl]methyl]-,1,1-dimethylethyl ester

Guidance on Safe Use

First-aid measures

Eye contact Rinse immediately with plenty of water for at least 15 minutes. Keep eye wide open while rinsing. Obtain medical attention.

Skin contact Take off contaminated clothing and shoes immediately. Wash off immediately with plenty

of water for at least 15 minutes. If skin irritation persists, call a physician.

alation Move to fresh air. Oxygen or artificial respiration if needed. Obtain medical attention.

Ingestion Obtain medical attention. Do NOT induce vomiting. Never give anything by mouth to an

unconscious person

Medical Surveillance Employees who are pregnant, are breast-feeding, or who are concerned with other

reproductive issues should be encouraged to consult with the occupational health physician

monitoring worker's health.

Fire-fighting measures

Flammable Properties Not readily combustible

Extinguishing Media Suitable extinguishing media: Dry chemical, Water spray, Foam

Unsuitable extinguishing media: Do NOT use water jet.

Protection of

Firefighters

Specific hazards: Not available

Protective equipment: Use personal protective equipment. In the event of fire, wear selfcontained

breathing apparatus.

Hazardous Combustion Products: carbon oxides (COx), nitrogen oxides (NOx)

Other information Avoid generating dust; fine dust dispersed in air in sufficient concentrations, and in the

presence of an ignition source is a potential dust explosion hazard. Decontaminate

protective clothing and equipment before reuse.

Accidental release measures

Personal precautions.

Use personal protective equipment.

Examples include tightly fitting safety goggles, lab coat and impervious gloves. Wear

respiratory protection. Depending on the nature of the spill (quantity and extent of spill)

additional protective clothing and equipment such as a self-contained breathing apparatus

may be needed.

Environmental

precautions

Prevent release to drains and waterways. Prevent release to the environment.

Containment Methods Wet down any dust to prevent generation of aerosols, if appropriate. Cover with suitable

material.

Cleanup Methods Contain and collect spillage and place in container for disposal according to local

regulations. Use a HEPA vacuum or moisten materials to minimize dust

generation during pick-up. Clean area with detergent and water after spill pick-up, if

appropriate. Handle waste materials, including gloves, protective clothing, contaminated

spill cleanup material, etc., as appropriate for chemically and pharmacologically similar

materials.

Other information Dust deposits should not be allowed to accumulate on surfaces, as these may form an

explosive mixture if they are released into the atmosphere in sufficient concentration.

Avoid dispersal of dust in the air (i.e., clearing dust surfaces with compressed air).

Nonsparking tools should be used.

Handling and storage

Handling Precautions Minimize dust generation and accumulation. Routine housekeeping should be instituted to

ensure that dusts do not accumulate on surfaces. Dry powders can build static electricity

charges when subjected to the friction of transfer and mixing operations. Provide adequate

precautions, such as electrical grounding and bonding, or inert atmospheres. Do not use in

areas without adequate ventilation. Avoid exposure - obtain

special instructions before use. Avoid formation of dust and aerosols. Keep away from

heat and sources of ignition. Prevent release to drains and waterways.

Container

Requirements

Store in sturdy containers appropriate to maintain the integrity of this material for its

intended use. Provide anti-static bags where drum liners are used.

Storage Conditions Store at room temperature in the original container. Protect against light. Keep away from

heat, sparks and flames.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:

Not listed

Shipping

SpecialProvisions

Inland waterway transport (UN RTDG/ADN(R))

UN number:

Not listed

Shipping

Remarks

Marine transport (UN RTDG/IMDG)

UN number:

Not Listed

Shipping

Remarks

Air transport (UN RTDG/ICAO/IATA)

UN number:

Not listed

Shipping

Remarks

SpecialProvisions

Exposure controls / personal protection

Engineering

Controls and

Ventilation

Use process enclosures, containment technology, or other engineering controls to keep

airborne levels below recommended exposure limit. When handling quantities up to 15

milligrams, a standard laboratory with general laboratory dilution ventilation (e.g. 6-12 air

changes per hour) is appropriate. When handling quantities from 15 milligrams to 1 kilogram,

work in a standard laboratory using a fume hood, biological safety cabinet(Class II, all types),

or approved vented enclosure. Quantities exceeding 1 kilogram should be handled in a

designated laboratory. A laminar flow/powder containment booth is recommended for

handling >1 kilograms of active substance. For manufacturing and pilot plant operations, use

direct coupling and closed transfer systems for all bulk transfers. Use dust tight valves as

appropriate. HEPA filtration of local exhaust ventilation (LEV) is required.

It is recommended that all dust control equipment such as local exhaust ventilation and

material transport systems involved in handling of this product contain explosion relief vents

or an explosion suppression system or an oxygen deficient environment. Ensure that dusthandling

systems (such as exhaust ducts, dust collectors, vessels, and processing equipment)

are designed in an manner to prevent the escape of dust into the work area (i.e., there is no

leakage from the equipment). Use only appropriately classified electrical equipment and

powered industrial trucks.

Respiratory

protection

Use and selection of respiratory protection is based upon engineering controls in use and

potential for aerosol generation. When engineering controls are not sufficient control

exposure, wear an approved respirator with NIOSH Class 100 or high efficiency particulate

(HEPA) filters or cartridges (EN 140/EN 136) when exposures are up to 10 times the exposure

control guideline. Wear a loose-fitting (Tyvek or helmet type) HEPA powered-air purifying

respirator (PAPR) (EN 12941) when exposures are 10-25 times the exposure control

guideline. Wear a full facepiece negative pressure respirator with Class 100 or HEPA filters

(EN 136) when exposures are 25-50 times the exposure control guideline. Wear a tightfitting,

full facepiece HEPA PAPR (EN 12942) when exposures are 50-100 times the exposure

control guideline. Wear a hood-shroud HEPA PAPR (EN 12941) or full facepiece supplied

air respirator (EN 139) operated in a pressure demand or other positive pressure mode when

exposures are 100-1000 times the exposure control guideline.

Eye protection Safety glasses with side-shields are recommended (EN 166). Face shields or chemical safety

goggles (EN 166) may be required if splash potential exists or if corrosive materials are

present. Note: Choice of eye protection may be influenced by the type of respirator which is

selected.

Hand protection Impervious nitrile, rubber and latex gloves are recommended (EN 420, EN 374). If material

is handled in solution, the solvent should also be considered when selecting protective clothing

material. Please note that employees who are allergic to natural rubber latex should use nitrile

gloves.

Skin and body

protection

Wear a laboratory coat (EN 340) when handling quantities up to 1 kilogram. For quantities

over 1 kilogram, wear laboratory coat(EN 340)or coverall of low permeability (EN 1149-1).

For manufacturing operations, wear coverall of low permeability (EN 465/1149-1). For

manufacturing operations, wear coverall of low permeability (EN 1149-1).

Hygiene Wash hands and face before breaks and immediately after handling the product.

Environmental

exposure controls

Prevent release to drains and waterways.

Stability and reactivity

Stability

Chemical

Stability

Stable under normal conditions.

Hazardous

decomposition

products

Hazardous decomposition products formed under fire conditions.: carbon oxides (COx),

nitrogen oxides (NOx)

Sensitivity to static discharge/Dust exp.

Explosion

Severity Factor

96 m.b_/s

St1

Material exhibits weak to moderate explosion characteristics if ignited as a dust cloud.

Minimum

Ignition Energy

3 - 10 mJ Material is extremely susceptible to igniting a dust cloud under certain conditions

due to low minimum ignition energy.

Volume

Resistivity

(ambient)

2.5000E+15 ohm.m

Material is highly susceptible to accumulating static charges during processing.

Charge decay

time (ambient)

2.3 Days

Summary

Statements

Powder handling equipment such as dust collectors, dryers, and mills may require additional

protective measures (e.g. explosion venting, inerting, etc.). Provide suitable bonding and

grounding for containers and process equipment to control static charges. Use of inert gas

should be considered for process conditions to minimize the risk of ignition. Provide antistatic

bags where drum liners are used. Provide suitable bonding and grounding for containers

and process equipment to control accumulation of static charges. Dust explosion severity risk can vary upon processing or

environmental change (e.g. milling, micronizing, sieving, blending or heating can increase the

risk of explosion), and may require additional dust explosion testing.

Disposal considerations

Advice On Disposal And Packaging Disposal should be in accordance with applicable regional, national and local

laws and regulations. Local regulations may be more stringent than regional

or national requirements. This information presented only applies to the

material as supplied.

Other information Disposal by incineration is recommended.