Physicochemical Information
Boiling point	40 °C (1013 hPa)
Density	1.33 g/cm3 (20 °C)
Evaporation number	1.9
Explosion limit	13 - 22 %(V)
Ignition temperature	605 °C DIN 51794
Melting Point	-95 °C
Vapor pressure	475 hPa (20 °C)
Solubility	20 g/l

Physicochemical Information

Boiling point

40 °C (1013 hPa)

Density

1.33 g/cm3 (20 °C)

Evaporation number

1.9

Explosion limit

13 - 22 %(V)

Ignition temperature

605 °C DIN 51794

Melting Point

-95 °C

Vapor pressure

475 hPa (20 °C)

Solubility

20 g/l

Toxicological Information
LD 50 oral	LD50 Rat 1600 mg/kg
LD 50 dermal	LD50 Rat > 2000 mg/kg

Toxicological Information

LD 50 oral

LD50 Rat 1600 mg/kg

LD 50 dermal

LD50 Rat > 2000 mg/kg

Safety Information according to GHS
Hazard Pictogram(s)
Hazard Statement(s)	H315: Causes skin irritation. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H351: Suspected of causing cancer.
Precautionary Statement(s)	P281: Use personal protective equipment as required. P302 + P352: IF ON SKIN: Wash with plenty of soap and 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. P308 + P313: IF exposed or concerned: Get medical advice/ attention.
Signal Word	Warning
RTECS	PA8050000
Storage class	6.1 D Non combustible, acute toxicity cat. 3 / toxic or substances with chronic effects
WGK	WGK 2 obviously hazardous to water
Disposal	2 Organic halogenated solvents and solutions of organic halogen-containing substances: For strongly contaminated or mixed halogenated solvents container B: Caution: Do not use aluminium containers; in addition, in the case of water-containing chlorinated waste materials do not use stainless-steel containers (danger of leaks caused by corrosion).

Safety Information according to GHS

Hazard Pictogram(s)

Hazard Statement(s)

H315: Causes skin irritation.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H351: Suspected of causing cancer.

Precautionary Statement(s)

P281: Use personal protective equipment as required.
P302 + P352: IF ON SKIN: Wash with plenty of soap and 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.
P308 + P313: IF exposed or concerned: Get medical advice/ attention.

Signal Word

Warning

RTECS

PA8050000

Storage class

6.1 D Non combustible, acute toxicity cat. 3 / toxic or substances with chronic effects

WGK

WGK 2 obviously hazardous to water

Disposal

2
Organic halogenated solvents and solutions of organic halogen-containing substances: For strongly contaminated or mixed halogenated solvents container B: Caution: Do not use aluminium containers; in addition, in the case of water-containing chlorinated waste materials do not use stainless-steel containers (danger of leaks caused by corrosion).

Safety Information
Hazard Symbols	Harmful
Categories of danger	carcinogenic
R Phrase	R 40 Limited evidence of a carcinogenic effect.
S Phrase	S 3-36/37 Keep in a cool place.Wear suitable protective clothing and gloves.

Safety Information

Hazard Symbols

Harmful

Categories of danger

carcinogenic

R Phrase

R 40
Limited evidence of a carcinogenic effect.

S Phrase

S 3-36/37
Keep in a cool place.Wear suitable protective clothing and gloves.

Storage and Shipping Information
Storage	Store at +15°C to +25°C.

Storage and Shipping Information

Storage

Store at +15°C to +25°C.

Transport Information
Declaration (railroad and road) ADR, RID	UN 1593 , 6.1, III
Declaration (transport by air) IATA-DGR	UN 1593 , 6.1, III
Declaration (transport by sea) IMDG-Code	UN 1593 , 6.1, III, Segregation Group: 10 (Liquid halogenated hydrocarbons)

Transport Information

Declaration (railroad and road) ADR, RID

UN 1593 , 6.1, III

Declaration (transport by air) IATA-DGR

UN 1593 , 6.1, III

Declaration (transport by sea) IMDG-Code

UN 1593 , 6.1, III, Segregation Group: 10 (Liquid halogenated hydrocarbons)

Specifications
Purity (GC)	≥ 99.0 %
Identity (IR)	conforms
Appearance of the substance	conforms
Acidic substances	conforms
Acidity (HCl)	≤ 0.001 %
Density (d 20 °C/20 °C)	1.320 - 1.332
Density (d 25 °C/25 °C)	1.318 - 1.322
Refractive index (n 20/D)	1.423 - 1.425
Free chlorine (Cl)	conforms
Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Ethanol)	≤ 2.0 % (v/v)
Ethanol,2-Methyl-2-butene and volatile impurities (GC) (2-Methyl-2-buten)	≤ 0.03 % (v/v)
Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Carbon tetrachloride (impurity A))	≤ 0.001 % (v/v)
Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Chloroform (impurity B))	≤ 0.005 % (v/v)
Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Total of impurities other than ethanol and 2-methyl-2-butene)	≤ 0.1 % (v/v)
Ethanol,2-Methyl-2-butene and volatile impurities (GC)(reportingthreshold)	≤ 0.005 % (v/v)
1,1-Dichloroethene (GC)	≤ 0.03 %
1,2-Dichloroethene (GC)	≤ 0.03 %
Other residual solvents (ICH Q3C)	excluded by manufacturing process
Evaporation residue	≤ 0.002 %
Water	≤ 0.020 %
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). The product is stabilized with about 50 ppm 2-Methyl-2-butene. Conforms to Ph Eur, BP, NF.

Specifications

Purity (GC)

≥ 99.0 %

Identity (IR)

conforms

Appearance of the substance

conforms

Acidic substances

conforms

Acidity (HCl)

≤ 0.001 %

Density (d 20 °C/20 °C)

1.320 - 1.332

Density (d 25 °C/25 °C)

1.318 - 1.322

Refractive index (n 20/D)

1.423 - 1.425

Free chlorine (Cl)

conforms

Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Ethanol)

≤ 2.0 % (v/v)

Ethanol,2-Methyl-2-butene and volatile impurities (GC) (2-Methyl-2-buten)

≤ 0.03 % (v/v)

Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Carbon tetrachloride (impurity A))

≤ 0.001 % (v/v)

Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Chloroform (impurity B))

≤ 0.005 % (v/v)

Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Total of impurities other than ethanol and 2-methyl-2-butene)

≤ 0.1 % (v/v)

Ethanol,2-Methyl-2-butene and volatile impurities (GC)(reportingthreshold)

≤ 0.005 % (v/v)

1,1-Dichloroethene (GC)

≤ 0.03 %

1,2-Dichloroethene (GC)

≤ 0.03 %

Other residual solvents (ICH Q3C)

excluded by manufacturing process

Evaporation residue

≤ 0.002 %

Water

≤ 0.020 %

Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
The product is stabilized with about 50 ppm 2-Methyl-2-butene.
Conforms to Ph Eur, BP, NF.

Documentation

Material Qualification Dossier

Title
EMPROVE® Material Qualification Dossier - 106049

Quality Management Dossier

Title
Dichloromethane EMPROVE® ESSENTIAL Ph Eur,BP,NF

Operational Excellence Dossier

Title
Dichloromethane EMPROVE® ESSENTIAL Ph Eur,BP,NF

Dichloromethane SDS

Title
Safety Data Sheet (SDS)

Dichloromethane Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
1060492500	Glass bottle	PDF Specification Document	Enter Lot Number
1.06049.6010	Drum stainl. st.	PDF Specification Document	Enter Lot Number
1.06049.6025	Drum stainl. st.	PDF Specification Document	Enter Lot Number
1060496190	Drum stainl. st.	PDF Specification Document	Enter Lot Number
1060499190	Steel barrel	PDF Specification Document	Enter Lot Number

Certificates

Title
Aflatoxin Certificate for 106049 Dichloromethane EMPROVE® ESSENTIAL Ph Eur,BP,NF
BSE/TSE Certificate for 106049 Dichloromethane EMPROVE® ESSENTIAL Ph Eur,BP,NF
GMO Certificate for 106049 Dichloromethane EMPROVE® ESSENTIAL Ph Eur,BP,NF
Halal Certificate for 106049 Dichloromethane extra pure
Kosher Certificate 106049 Dichloromethane suitable for use as excipient EMPROVE® exp Ph Eur,BP,NF

Documentation

Material Qualification Dossier

Quality Management Dossier

Operational Excellence Dossier

Dichloromethane SDS

Dichloromethane Certificates of Analysis

Certificates

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