Home › Pancreatin NB GMP Grade from porcine pancreas
Pancreatin NB GMP Grade from porcine pancreas
Pancreatin NB GMP Grade is derived from porcine pancreas of known origin. It
meets the requirements of the European Pharmacopoeia monograph for pancreas
powder and is manufactured according to EU guidelines to Good Manufacturing
Practice (GMP). Pancreatin is a mixture of digestive enzymes and contains
lipolytic, amylolytic and proteolytic activities. Specification: Lipolyticactivity:
≥ 80 000 Ph. Eur. U/g Amylolytic activity: ≥ 60 000 Ph. Eur. U/g Proteolytic
activity: ≥ 3 000 Ph. Eur. U/g Loss on drying: ≤ 3.0 % Fat
content: ≤ 3.0 % Microbiological examination: Total aerobic
microbial count (TAMC): ≤104 CFU/g Total yeast and mould
count (TYMC): ≤102 CFU/g Absence of Escherichia coli:
must comply Absence of Salmonella: must comply
Unit definitions: Lipolytic Activity (Ph. Eur.) The
lipolytic activity is determined by comparing the rate at which a suspension
of pancreas powder hydrolyses a substrate of olive oil emulsion with the rate
at which a suspension of pancreas powder (amylase and lipase) BRP hydrolyses
the same substrate under the same conditions. The test is carried out under
nitrogen. Amylolytic Activity (Ph. Eur.) The amylolytic activity is
determined by comparing the rate at which a suspension of pancreas powder
hydrolyses a substrate of starch solution with the rate at which a suspension
of pancreas powder (amylase and lipase) BRP hydrolyses the same substrate
under the same conditions. Proteolytic Activity (Ph. Eur.) The
total proteolytic activity of pancreas powder is determined by comparing the
quantity of peptides non-precipitable by a 50 g/l solution of trichloroacetic
acid R released per minute from a substrate of casein solution with the
quantity of such peptides released by pancreas powder (protease) BRP from the
same substrate in the same conditions.
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BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang behutsam mit Wasser spülen.
Vorhandene Kontaktlinsen nach Möglichkeit entfernen. Weiter spülen.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
EN CAS DE CONTACT AVEC LES YEUX: rincer avec précaution à l’eau pendant plusieurs minutes. Enlever les lentilles de contact si la victime en porte et si elles peuvent être facilement enlevées. Continuer à rincer
IN CASO DI CONTATTO CON GLI OCCHI: sciacquare accuratamente per parecchi minuti. Togliere le eventuali lenti a contatto se è agevole farlo. Continuare a sciacquare.
EN CASO DE CONTACTO CON LOS OJOS: Aclarar cuidadosamente con agua durante varios minutos. Quitar las lentes de contacto, si lleva y resulta fácil. Seguir aclarando.