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Safety Data Sheet EN

ClinChek® Plasma Control for Lamotrigine and Sulthiame, Level I, II, lyophil.

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
ClinChek® Plasma Control for Lamotrigine and Sulthiame, Level I, II, lyophil.
Product Form
lyophil.
Product Code
15180, 15181, 15182

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Controls for in-vitro diagnostic use (quality control of the HPLC analysis)

Manufacturers & Suppliers

R

RECIPE Chemicals + Instruments GmbH

manufacturer

Dessauerstraße 3, D-80992 München, Germany

+49 / 89 / 54 70 81 -18

Emergency Contacts

Poison Control Centre (Giftnotruf München, Germany)

+49 / 89 / 192 40

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified no signal word

GHS Pictograms

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

Lyophilized plasma of human origin, spiked with Lamotrigine and Sulthiame.

Chemical Name CAS Number Concentration Hazardous
Lyophilized plasma of human origin --- --- No
Lamotrigine --- --- No
Sulthiame --- --- No

Notes

The amount of harmful substances (single and total amount), as specified in the directive 67/548/EEC, is below the limits of classification.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Fresh air

Skin contact

Wash off with plenty of water

Eye contact

Rinse out with plenty of water (with eyelid held wide open for at least 15 min). Call in ophthalmologist.

Ingestion

Rinse mouth with water; afterwards drink plenty of water.

Immediate Medical Attention

Call in ophthalmologist.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

In adaption to materials stored in the immediate neighbourhood. Product is inflammable.

Unsuitable media

Not applicable

Specific hazards

No data available

Firefighter Protection

Do not stay in dangerous zone without suitable chemical protection clothing and self-contained breathing apparatus.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Environmental

Not applicable

Cleanup methods

Take up dry, forward for disposal and clean up affected area.

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

see TRGS 500 (Germany): protective measures – minimum standards.

Storage

Keep only in the original container.

Fire prevention

Not applicable

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Hands

Protection gloves recommendable; see section 2

Eyes

safety glasses

Respiratory

not required, if the product is used according to the intended purpose

Skin/Body

lab coat. Protective clothing should be selected specifically for the working place, depending on concentration and quantity of the hazardous substances handled. The resistance of the protective clothing to chemicals should be ascertained with the respective supplier.

Environmental

see sections 6 and 7.

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Solidification Point
---
Evaporation Rate
---
Partition Coefficient
---
Properties Status
---
Kinematic Viscosity
---
Solubility In Fat
---
Flammability
---
Vapor Density
---
Odor
odourless
Colour
colourless
Crystallisation Point
---
Relative Density
---
Form
---
Voc Content
---
Density
not applicable
Dynamic Viscosity
---
Ph
not applicable
Vapor Pressure
not applicable
State Under Standard Conditions
---
Odor Threshold
---
Appearance
solid, colourless, odourless
Freezing Point
---
Boiling Point
not applicable
Softening Point
---
Cloud Point
---
Solubility In Water
completely soluble
Colour Intensity
---
Metal Corrosion
---
Flash Point
not applicable
Lower Explosive Limit
not applicable
Decomposition Temperature
---
Explosive Limits
---
Melting Point
---
Physical State Data
solid
Upper Explosive Limit
not applicable
Molecular Weight
---
Auto Ignition Temperature
not applicable
Solubility
---
Physical State
solid
Bulk Density
---
Relative Evaporation Rate
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Avoid

In case the product is used according to the intended purpose, hazardous reactions must not be anticipated.

Decomposition

No data available

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

The data for this section has not been processed yet.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Laboratory waste should be collected separately with regard to its different chemical properties.

Disposal

Waste of this product should be collected and disposed like the patient samples.

14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for ClinChek® Plasma Control for Lamotrigine and Sulthiame, Level I, II, lyophil.?

The signal word is no signal word.

What is the physical form of ClinChek® Plasma Control for Lamotrigine and Sulthiame, Level I, II, lyophil.?

ClinChek® Plasma Control for Lamotrigine and Sulthiame, Level I, II, lyophil. is a solid appearing as solid, colourless, odourless with colourless color. It has odourless odor.

What is ClinChek® Plasma Control for Lamotrigine and Sulthiame, Level I, II, lyophil. used for?

Controls for in-vitro diagnostic use (quality control of the HPLC analysis)