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Safety Information

1.01736

Sigma-Aldrich

OSTEOMOLL®

Solution for rapid decalcification (with fixation) for histology

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UNSPSC Code:
12352401
NACRES:
NA.21

Quality Level

form

liquid

IVD

for in vitro diagnostic use

color

blue

pH

<1 (20 °C in H2O)

density

1.10 g/mL at 20 °C

application(s)

diagnostic assay manufacturing
hematology
histology

storage temp.

15-25°C

General description

OSTEOMOLL® - Solution for rapid decalcification (with fixation) for histology, is used for human cell diagnostics and serves to decalcify (demineralize) bone tissue (e. g. punched bone-marrow specimens) and other hard materials and to soften keratinized tissue of human origin, fixing the specimens in the same process.
Decalcification is necessary for optical microscopic examinations of hard tissue in routine histological procedures. For the decalcification of sensitive, calcium-containing tissues, such as iliac crest biopsies, OSTEOSOFT® (Product number 1.01728) can be used. Its formulation is based on EDTA. Its pendant, OSTEOMOLL®, can be used for the decalcification of hard tissue such as teeth and bone as its formulation is based on formaldehyde and hydrochloric acid. The amount of OSTEOMOLL® needed is dependent upon on the size, type and thickness of the material. A 30 ml portion of OSTEOMOLL®, which should completely cover the material, can be used twice if the solution is still clear and not contaminated.
The material must first be cut to a thickness of max. 5 mm and an area of 6 cm2 (= max. Embedding cassette size). Both solutions are color-coded, to distinguish them from each other, fixatives and solvents used in the histological laboratory. OSTEOSOFT® is color-coded yellow, OSTEOMOLL® is color-coded blue. Whereby OSTEOSOFT® preserves the antigen structures in the tissue, thus, an IHC analysis can be performed, OSTEOMOLL® will be used for tissues that are not destined for antibody analysis.
Both decalcifiers can be used for clinical diagnostic purposes and in laboratory accreditation processes as they are certified and registered as IVD and CE product. The quantity of OSTEOMOLL® required is dependent on the size, type, and density of the respective material. For more details, please see instructions for use (IFU). The IFU can be downloaded from this webpage.

Analysis Note

Performance test: passes test

Legal Information

OSTEOMOLL is a registered trademark of Merck KGaA, Darmstadt, Germany
OSTEOSOFT is a registered trademark of Merck KGaA, Darmstadt, Germany

Signal Word

Danger

Hazard Classifications

Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Carc. 1B - Eye Dam. 1 - Met. Corr. 1 - Muta. 2 - Skin Corr. 1 - Skin Sens. 1 - STOT SE 3

Target Organs

Respiratory system

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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