Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
1 of 11
Section 1 - Identification
(a) Product Identifier:
(b) Product Code:
Common/Trade Name:
Chemical Name:
Chemical Family:
(c) Product Use:
Octreotide Acetate Injection
25021-451
25021-452
25021-453
25021-454
25021-455
Sandostatin®
L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanylD-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1(hydroxymethyl)propyl]-, cyclic (2→7)-disulfide; [R-(R*,
R*)] acetate salt
Cyclic octapeptide
Octreotide Acetate Injection is indicated to reduce blood levels
of growth hormone and IGF-I (somatomedin C) in acromegaly
patients who have had inadequate response to or cannot be
treated with surgical resection, pituitary irradiation, and
bromocriptine mesylate at maximally tolerated doses
Carcinoid Tumors
Octreotide Acetate Injection is indicated for the symptomatic
Treatment of patients with metastatic tumors where it
suppresses or inhibits the severe diarrhea and flushing episodes
associated with the disease.
Vasoative Intestinal Peptide Tumors (VIPomas)
Octreotide Acetate Injection is indicated for the treatment of
the profuse watery diarrhea associated with VIP-secreting
tumors.
Product Type:
Container Information:
(d) Distributor:
(e) Emergency Telephone:
Regulated Prescription Drug
Vials
Sagent Pharmaceuticals, Inc., 1901 N. Roselle Rd, Suite 700,
Schaumburg, IL 60195, 847-908-1600
866-625-1618
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
2 of 11
Section 2 - Hazards Identification
(a) Classification:
(b) Signal Word,
Hazard statement(s),
Symbol(s), and/or
Precautionary statement(s):
(c) Description of Hazards:
(d) Unknown Acute Toxicity:
NFPA Rating
Health Hazard
1
Fire Hazard
0
Reactivity Hazard
0
Not available; minimal adverse effect should occur from
routine handling of this product.
Not available; minimal adverse effect should occur from
routine handling of this product.
N/A
Section 3 – Composition / Information on Ingredients
(a) Chemical Name
(b) Common
Name /
Synonym
L-Cysteinamide, Dphenylalanyl-L-cysteinylL-phenylalanyl-Dtryptophyl-L-lysyl-Lthreonyl-N-[2-hydroxy-1(hydroxymethyl)propyl]-,
cyclic (2→7)-disulfide;
[R-(R*, R*)] acetate salt
Octreotide
Acetate
Sodium Chloride
Sodium Chloride
% Composition or
other measure
(c) CAS No.
200
1000
mcg/mL mcg/mL
0.2
mg/mL
1.0
mg/mL
7.0
mg/mL
2.0
mg/mL
2.0
mg/mL
5.0
mg/mL
7.0
mg/mL
2.0
mg/mL
2.0
mg/mL
5.0
mg/mL
79517-01-4
N/A
7647-14-5
N/A
Glacial Acetic
64-19-7
Acid, USP
Sodium Acetate
Sodium Acetate
6131-90-4
Trihydrate, USP
Phenol
Phenol
108-95-2
Liquefied, USP*
Water for
Water
Balance
7732-18-5
Injection
* Product codes 25021-454 and 25021-455 contain excipient as preservative.
Acetic Acid
(d)
Impurities /
Stabilizing
Additives
N/A
N/A
N/A
N/A
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
3 of 11
(a) Chemical Name
L-Cysteinamide, Dphenylalanyl-Lcysteinyl-Lphenylalanyl-Dtryptophyl-L-lysylL-threonyl-N-[2hydroxy-1(hydroxymethyl)pro
pyl]-, cyclic (2→7)disulfide; [R-(R*,
R*)] acetate salt
Sodium Chloride
Acetic Acid
Sodium Acetate
Nitrogen,! NF
Water
!
Safety Data Sheet (SDS)
(b) Common
Name /
Synonym
% Composition or other
measure
50
mcg/mL
(1mL)
1000
mcg/mL
(1mL)
500
mcg/mL
(1mL)
Octreotide
Acetate
0.05
mg/mL
0.1
mg/mL
0.5
mg/mL
Sodium
Chloride
Glacial Acetic
Acid, USP
Sodium
Acetate
Trihydrate,
USP
Nitrogen
Water for
Injection
7.0
mg/mL
2.0
mg/mL
7.0
mg/mL
2.0
mg/mL
7.0
mg/mL
2.0
mg/mL
2.0
mg/mL
2.0
mg/mL
2.0
mg/mL
q.s
q.s to 1
ml
q.s
q.s to 1
ml
q.s
q.s to 1
ml
(c) CAS No.
(d)
Impurities /
Stabilizing
Additives
79517-01-4
N/A
7647-14-5
N/A
64-19-7
N/A
6131-90-4
N/A
7727-37-9
N/A
7732-18-5
N/A
Nitrogen gas is used as an inert gas
Section 4 - First Aid Measures
Eye Exposure:
Flush eyes with large volumes of water for 15 or more minutes. Get
medical attention if irritation or signs of exposure are noted.
Skin Exposure:
Remove contaminated clothing, wash skin with water and soap for 15
minutes. Get medical attention if irritation or signs of exposure are
noted.
Ingestion:
If ingestion occurs, flush mouth with water and seek medical attention
immediately. Never give anything by mouth to an unconscious person.
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
4 of 11
Injection:
In cases of accidental injection, wash and disinfect area, get medical
attention.
Inhalation:
If difficulty with breathing, remove from exposure, administer oxygen.
Seek attention of a physician immediately. When appropriate and
trained in CPR, provide artificial respiration.
Notes to Physician:
See patient package insert in shipping carton for complete information.
Section 5 –Fire-fighting Measures
(a)
Extinguishing Media
Use water or an ABC multi-purpose extinguisher.
(b)
Hazardous
Combustion
Products:
Heat of the fire could cause vials or syringes to burst.
(c)
Special Protective
Equipment /
Precautions:
As with all fires, evacuate personnel to a safe area. Fire fighters
should wear self-contained breathing apparatus to avoid
inhalation of smoke. Product is aqueous-based and is not
expected to present a fire hazard concern.
Section 6 - Accidental Release Measures
Spill:
Absorb Octreotide Acetate with absorbent materials and dispose
according to local, state and federal guidelines.
Release to Air:
If aerosolized, reduce exposures by ventilating area.
Release to Water:
Refer to local water authority. Drain disposal is not recommended;
refer to local, state, and federal disposal guidelines.
Section 7 - Handling and Storage
General Handling:
Wear latex or nitrile gloves and safety glasses, and an air-purifying
respirator with HEPA (P100) cartridges when cleaning spills.
Storage Conditions:
Store refrigerated between 2º and 8ºC (36º and 46ºF). At room
temperature, (20º to 30ºC or 70º to 86ºF), Octreotide Acetate Injection
is stable for 14 days if protected from light. The solution can be
allowed to come to room temperature prior to administration. Do not
warm artificially.
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
5 of 11
Section 8 - Exposure Controls / Personal Protection
(a) Exposure Limits
Compound
Octreotide
Issuer
ACGIH
----OSHA
-----
Sodium Chloride
ACGIH
----OSHA
-----
Glacial Acetic Acid, USP
ACGIH
----OSHA
-----
Sodium Acetate Trihydrate USP
ACGIH
----OSHA
-----
Phenol Liquefied, USP
ACGIH
----OSHA
-----
Water for Injection
ACGIH
----OSHA
-----
Type
TLV
STEL
PEL
STEL
Other
TLV
STEL
PEL
STEL
Other
TLV
STEL
PEL
STEL
Other
TLV
STEL
PEL
STEL
Other
TLV
STEL
PEL
STEL
Other
TLV
STEL
PEL
STEL
Other
(b) Engineering Controls
Ventilation:
Handle product in a well-ventilated area.
Exposure Limit
NE
NE
NE
NE
NE
NE
NE
NE
NE
NE
10 ppm
15 ppm
10 ppm
NE
NE
NE
NE
NE
NE
NE
5 ppm
NE
5 ppm-SKIN
NE
NE
NE
NE
NE
NE
NE
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
6 of 11
(c) Individual Protection Measures
Respiratory
Protection:
Under normal use, respirators are not required. If aerosols are
generated, an air-purifying respirator with HEPA (P100)
cartridges. Personnel wearing respirators should be fit tested and
approved for respirator use under the OSHA Respiratory
Protection Standard 29 CFR 1910.134.
Eye Protection:
Safety glasses
Skin Protection:
Latex or Nitrile gloves
Other Protective
Equipment:
Lab coat
Additional Exposure
Precautions:
Wash hands following use. No eating , drinking or smoking while
handling this product.
Section 9 - Physical and Chemical Properties
(a)
Appearance
(b)
Odor
Clear, Colorless Liquid
Not available
(c)
Odor Threshold
Not available
(d)
pH
(e)
Melting Point:
3.9 – 4.5
Approx. 0ºC
(f)
Initial Boiling Point:
Approx. 100ºC
(g)
Flash Point
Not available
(h)
Evaporation Rate:
Approx to water
(i)
Flammability
Not available
(j)
Upper Lower Flammability or Explosion Limits
Not available
(k)
Vapor Pressure:
Not available
(l)
Vapor Density:
Similar to water
(m)
Relative Density
Specific Gravity – 1 at 20ºC
(n)
Solubility(ies)
(o)
Partition Coefficient: n-octanol/water
Soluble in water
Not available
(p)
Auto-ignition Temperature
Not available
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
7 of 11
(q)
Decomposition Temperature
Not available
(r)
Viscosity
Not available
Section 10 - Stability and Reactivity
Not determined
Stable
(a)
Reactivity
(b)
Chemical Stability
(c)
Possibility of Hazardous Reactions
(d)
Conditions to Avoid
Hazardous polymerization will not occur
None identified
(e)
Incompatible Materials
None identified
Hazardous Decomposition Products
Decomposition products of this compound may
include potentially hazardous byproducts such
as oxides of nitrogen
(f)
Section 11 - Toxicological Information
(a)
Likely Routes of Exposure
(b)
Symptoms related to the physical,
chemical and toxicological
characteristics
(c)
Delayed and immediate effects and
also chronic effects from short and
long term exposure
May be absorbed via contact with skin or eyes,
inhalation of aerosols or accidentally ingested.
Under normal use with supervision of a
physician, Octreotide Acetate Injection presents
little hazard.
Affects the pituitary gland and digestive
systems. Minimal adverse effect should occur
from routine handling of this product. Acute
signs and symptoms of overexposure may
include nausea, vomiting, irritation to the skin
and respiratory tract. It may also cause
production of gall stones. Product may cause
allergic reactions in persons sensitive to
Octreotide Acetate.
Exposure can cause irritation to eyes, skin and
respiratory system, nausea, vomiting and gall
stones.
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
8 of 11
(d) Acute Toxicity
Component
Type
Octreotide
TDLO
Acetate
Octreotide
LD50
Acetate
Octreotide
LD50
Acetate
Octreotide
LD50
Acetate
Octreotide
LD50
Acetate
Octreotide
LD50
Acetate
(e) Hazardous Chemical Listings
NTP: No
IARC: No
Route
Subcutaneous
Species
Human
Dosage
=1429 ug/kg
Subcutaneous
Rat
>50 mg/kg
Subcutaneous
Mouse
>0.1 mg/kg
Subcutaneous
Mammal, Dog
>20 mg/kg
Intravenous
Rat
=72300 ug/kg
Intravenous
Mouse
=18.100 mg/kg
OSHA: No
Section 12 - Ecological Information
(a)
Ecotoxicity
Not available
(b)
Persistence and degradability
Not available
(c)
Bioaccumulative potential
Not available
(d)
Mobility in soil
Not available
(e)
Other Adverse Effects
Not available
Section 13 - Disposal Considerations
Incineration in an approved incinerator is recommended Refer to local, state and federal rules.
Section 14 - Transport Information
(a)
UN Number
Not available
(b)
UN Proper Shipping Name
Not available
(c)
Transport Hazard Class(es)
Not available
(d)
Packing Group
Not available
(e)
Environmental Hazards
Not available
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
Page:
May 18, 2015
SDS 060
2.0
R-SOP-009-F001
9 of 11
(f)
Transport in bulk (according to
Annex II of MARPOL 73/78 and the
IBC Code)
Not available
(g)
Special Precautions
Not available
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Sagent usage. This
section is not a complete analysis or reference to all applicable regulatory information. Please
consider all applicable laws and regulations for your country/state.
U.S. Regulations:
TSCA - No
CERCLA - Not on this list
SARA 313 - Not on this list
RCRA – Not on this list
Section 16 - Other Information
As of the date of issuance, we are providing available information relevant to the handling of this
material in the workplace. All information contained herein is offered with the good faith belief
that it is accurate. THIS SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE
ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident
associated with this material, this safety data sheet is not intended to be a substitute for
consultation with appropriately trained personnel. Nor is this safety data sheet intended to be a
substitute for product literature which may accompany the finished product.
For additional information contact:
Sagent Pharmaceuticals, Inc.
1901 N. Roselle Rd, Suite 700
Schaumburg, IL 60195
847-908-1600
Glossary: This glossary contains definitions of general terms used in SDSs. Not all of these
Glossary Terms will apply to this SDS.
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
ACGIH
AICS
AIHA
ANSI
CAS Number
CERCLA
CHAN
CHEMTREC
DOT
DSL
ECHA
EINECS
ELINCS
EPA
GHS
HEPA
HMIS
IARC
ICAO/IATA
IMDG
IMO
KOW
LEL
MSDS
MSHA
NA
NE
NADA
NAIF
NCI
NDSL
NFPA
NIOSH
NPDES
NOS
NTP
OSHA
OEL
PEL
RCRA
RQ
RTECS
SARA
SDS
STEL
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
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May 18, 2015
SDS 060
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R-SOP-009-F001
10 of 11
American Conference of Governmental Industrial Hygienists
Australian Inventory of Chemical Substances
American Industrial Hygiene Association
American National Standards Institute
Chemical Abstract Service Registry Number
Comprehensive Environmental Response Compensation and Liability Act (of 1980)
Chemical Hazard Alert Notice
Chemical Transportation Emergency Center
Department of Transportation
Domestic Substances List
European Chemicals Agency
European Inventory of Existing Commercial Chemical Substances
European List of Notified Chemical Substances
Environmental Protection Agency
Globally Harmonized System of Classification and Labelling of Chemicals
High Efficiency Particulate Air (Filter)
Hazardous Materials Identification System
International Agency for Research on Cancer
International Civil Aviation Organization/International Air Transport Association
International Maritime Dangerous Goods
International Maritime Organization
Octanol/Water Partition Coefficient
Lower Explosive Limit
Material Safety Data Sheet
Mine Safety and Health Administration
Not Applicable, except in Section 14 where NA = North America
Not Established
New Animal Drug Application
No Applicable Information Found
National Cancer Institute
Non-Domestic Substances List
National Fire Protection Association
National Institute for Occupational Safety and Health
National Pollutant Discharge Elimination System
Not Otherwise Specified
National Toxicology Program
Occupational Safety and Health Administration
Occupational Exposure Limit
Permissible Exposure Limit (OSHA)
Resource Conservation and Recovery Act
Reportable Quantity
Registry of Toxic Effects of Chemical Substances
Superfund Amendments and Reauthorization Act
Safety Data Sheet
Short Term Exposure Limit
Sagent Pharmaceuticals, Inc.
Octreotide Acetate Injection
TLV
TPQ
TSCA
TWA
UEL
UN
USP
WEEL
WHMIS
Safety Data Sheet (SDS)
SDS Issue Date:
SDS No.:
SDS Version No.:
Form No.:
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May 18, 2015
SDS 060
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R-SOP-009-F001
11 of 11
Threshold Limit Value (ACGIH)
Threshold Planning Quantity
Toxic Substances Control Act
Time Weighted Average/8 Hours Unless Otherwise Noted
Upper Explosive Limit
United Nations
United States Pharmacopeia
Workplace Environmental Exposure Level (AIHA)
Workplace Hazardous Materials Information System