Sitagliptin / Simvastatin Formulation

Merck & Co., Inc

Revision date : 2025-12-06

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GHS08 GHS07
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

>=5-<=10

EC/CAS

9005-25-8

Name of the chemical

Starch

Concentration

>=3-<=7

EC/CAS

50-81-7

Name of the chemical

Ascorbic acid C6H8O6

Concentration

>=0.5-<=1.5

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

>=0.1-<=1

EC/CAS

14807-96-6

Name of the chemical

Talc

Concentration

>=0.1-<=1

General Information

Version

13.0

Revision date

2025-12-06

Product name

Sitagliptin / Simvastatin Formulation

1.2.1 Relevant identified uses

Pharmaceutical

supplier name

Merck & Co., Inc

Emergency telephone

1-908-423-6000

Icons in SDS

GHS07 GHS08 M004 M009 M010 M011 M013 M017 M059

Company Information

company name

Merck & Co., Inc

e-mail address of the competent person responsible for the Safety Data Sheet

EHSDATASTEWARD@merck.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H317, H319, H372

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

Other hazards

None known. Hazards associated with a change in physical form Conditions Hazards If small particles are generated during further May form combustible dust concentrations in processing, handling or by other means. air.

Signal word

Danger

Hazard statements

H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H372 Causes damage to organs (Liver, muscle, optic nerve, Eye) through prolonged or repeated exposure.

Prevention

P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P272 Contaminated work clothing must not be allowed out of the workplace. P280 Wear protective gloves, eye protection and face protec- tion.

Response

P302 + P352 IF ON SKIN: Wash with plenty of water. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P314 Get medical attention if you feel unwell. P333 + P313 If skin irritation or rash occurs: Get medical atten- P337 + P313 If eye irritation persists: Get medical attention. P362 + P364 Take off contaminated clothing and wash it before reuse.

Disposal

P501 Dispose of contents and container to an approved waste disposal plant.

2.1 Classification of the substance or mixture

1910.1200) Hazards for the product as supplied Eye irritation : Category 2A Skin sensitization : Category 1 Specific target organ toxicity : Category 1 (Liver, muscle, optic nerve, Eye) - repeated exposure Other hazards None known. Hazards associated with a change in physical form: Conditions Hazards If small particles are generated during further May form combustible dust concentrations in processing, handling or by other means. air.

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