MSDS Lactose Monohydrate (SuperTab 11 SD - NZ)

Safety Information
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Acrobat. Product group: Lactose, Inhalation
Brand name: Lactochem®, Lactohale®,
Lactopress®,
Pharmatose®, SuperTab®,
Respitose®
Product description:Lactose monohydrate
Document No.: PD-0278 Page 1 of 5
Safety Information
 This product is not a dangerous product according to the applicable United Nations rules;
 The Safety Information is provided as a service to our customers and there is no legal
obligation in the European Union to provide it in your national language and in the format of
the Regulation (EC) 1907/2006 (consolidated);
 This safety information provides hazard information according to 29 CFR 1910.1200(a)(2);
 This document should be read in conjunction with the Ingredient Declaration and Certificate
of Standards/Product Specification for the relevant product or product category
1. Product and company identification

Product name: Lactochem®, Lactohale®, Lactopress®, Pharmatose®, SuperTab®, Respitose®
Cas Number; 64044-51-5: Official quote in current Japanese Pharmacopoeia / Official in Brazil
(Anvisa) Identified uses; Excipient used in the manufacturing of pharmaceutical products
Manufacturer/supplier identification: See Footer
2. Hazards Identification
No hazardous product as specified in the current EU legislation and in UN-rules.
GHS-US classification; combustible dust.
Warning! May form combustible dust concentrations in air (during processing)
3. Composition/information on ingredients
See Ingredient Declaration and the Product Specification
For D-(+)-Lactose monohydrate the following CAS number is applicable:
CAS No.: 64044-51-5: Official quote in current Japanese Pharmacopoeia / Official in Brazil (Anvisa)
EINECS No.: 200-559-2 Molecular weight: 360,3 g/mol

RTECS No.: OD9625000 Formula: C12H22O11 xH2O
Safety Information
Lactopress®,
Respitose®
4. First aid measures
After inhalation: fresh air

After skin contact: wash off with plenty of water.
After eye contact: rinse out with water.
After swallowing (large amounts): get medical attention.
5. Fire-fighting measures
Explosion; Avoid generating dust; fine dust dispersed in air in sufficient concentrations, and in the
presence of an ignition source (e.g. static electricity) is a potential dust explosion hazard
This product is flammable. Suitable extinguishing media: water, powder, spray foam, CO2
In adaptation to materials stored in the immediate neighborhood.
6. Accidental Release measures

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)
Non sparking tools should be used
7. Handling and storage

For safety reasons, store in tightly closed packing protected from solvents.
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.
8. Exposure controls/personal protection

Respiratory protection required when dusts are generated.
Eye protection is required.
The use of hand protection is recommended.
Wash hands after working with substance.
Safety Information
Lactopress®,
Respitose®
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 dust-handling systems (such as exhaust ducts, dust collectors, vessels, and processing
equipment) are designed in a 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.
9. Physical and chemical properties
For chemical and physico-chemical data see the Certificate of Standards (COS)
10. Stability and reactivity

Like any other powdered product, there is a risk of explosion in a confined cloud (combustible dust
formation)
LEL g/m³ Pmax Bar Kst bar.m/s MIE mJ

30 - 125 6.3 – 8,9 24 - 121 1000 mJ (lactose
monohydrate)
10 mJ (lactose
monohydrate,
micronized)
MIT °C Smoulder °C Dust Explosion class
360-470 300-360 ST1
LEL= Lower explosion limit; Pmax= Maximum explosion pressure; Kst=Maximum rate of pressure rise;
MIE= Minimum ignition energy; MIT= Determination of the minimum ignition temperature;
Smoulder= Smoulder temperature
11. Toxicological information

No toxic effects are to be expected when the product is handled appropriately
Safety Information
Lactopress®,
Respitose®
12. Ecological information

No ecological problems are to be expected when the product is handled and used with due care
and attention.
13. Disposal considerations

Products and Packaging
There are no uniform EC Regulations for the disposal of chemicals or residues. Chemical residues
generally count as special waste. The disposal of the latter is regulated in the EC member countries
through corresponding laws and regulations. We recommend that you contact either the authorities
in charge or approved waste disposal companies which will advise you on how to dispose of special
waste.
14. Transport information

Not subject to limitations due to transport regulations.
15. Regulatory information

Labeling according to applicable local legislation; Keep away from sources of ignition – No smoking
16. Other information

Please refer to;
NFPA 654, Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing,
and Handling of Combustible Particulate Solids, for safe handling
OSHA information on combustible dusts;
https://www.osha.gov/pls/publications/publication.athruz?pType=Industry&pID=250
ATEX Directive 2014/34/EU

Safety Information
Lactopress®,
Respitose®
This statement substitutes all previous versions issued for the brand names mentioned above.
We trust this information, which is made up to the best of our knowledge, will be helpful to you.
The information given in this document is based on our current knowledge and experience, however
without any obligation and without any assumption of liability on our part. The information may be
used at your discretion and risk. It does not relieve you from carrying out your own precautions and
tests. You must comply with all applicable laws, rules and regulations and observe all third party
rights.

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Safety Information

1. Product and company identification

Warning! May form combustible dust concentrations in air (during processing)

EINECS No.: 200-559-2 Molecular weight: 360,3 g/mol

4. First aid measures

After inhalation: fresh air

6. Accidental Release measures

7. Handling and storage

8. Exposure controls/personal protection

10. Stability and reactivity

LEL g/m³ Pmax Bar Kst bar.m/s MIE mJ

11. Toxicological information

12. Ecological information

13. Disposal considerations

14. Transport information

15. Regulatory information

16. Other information

OSHA information on combustible dusts;

ATEX Directive 2014/34/EU

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