European
Pharmacopoeia 8th Edition - Review of Supplement 8.3
Below
is a list of monographs and general chapters that are new, or that have been
revised, corrected or deleted for the 8th Edition (supplement 8.3) of the European
Pharmacopeia.
General
Chapters
2.2.29 Liquid
Chromatography
The
chapter has been revised to include a reference to LC systems using short
columns and reduced particle-size stationary phases, such as sub-2 µm
particles, and mobile phases at high pressure but avoiding reference to trading
names such as e.g. UPLC, RRLC, etc.
2.4.22 Composition
of fatty acids by gas chromatography
Content
of oleic acid: sentence added to clarify that content of oleic acid is sum of
oleic acid (18:1 n-9) and cis-vaccinic acid (18:1 n-7)
2.7.5 Assay
of Heparin
The
clotting assay in sheep plasma has been replaced by a more specific chromogenic
assay for anti-factor IIa activity following an international collaborative
study (Gray E., Hogwood J., Rigsby P. et al. An international collaborative
study to value assign the 6th international standard for unfractionated heparin
and the US pharmacopeial heparin reference standard for assay lot F. Ref:
WHO/BS/09.2124. WHO Expert Committee on Biological Standardization; 2009).
The
revised chapter also comprises an assay for anti-factor Xa activity, which is
used to establish the ratio of anti-factor Xa to anti-factor IIa activity, used
as an identification criterion in the unfractionated heparin monographs (heparin
sodium (0333), heparin calcium (0332)). As part of this revision, heparin
sodium BRP was recalibrated for use with these new methods.
3.2.1 Glass
containers for pharmaceutical use
Production:
section introduced to address the risk related to potential delamination of
glass containers, by raising awareness of the glass manufacturers and users of
the glass containers in the pharmaceutical industry to the factors contributing
to the phenomenon
Harmonisation
with ISO 4802-1 and 4802-2: adjustments made to avoid ambiguities with ISO,
including an additional volume specification for containers of 2-3 mL in Table
3.2.1.-3 and Table 3.2.1.-7
Hydrolytic
resistance of glass grains: alternative grinding device introduced to include
state-of-the-art equipment that increases reproducibility of sample
preparation.
Monographs
Acetic acid, glacial (0590)
Reducing
substances: test revised to replace potassium dichromate (proscribed under
REACH regulation).
Ethanol (96 per cent) (1317)
Volatile
impurities: formula for calculation of the content of acetaldehyde and acetal
has been corrected.
Heparin sodium (0333)
Definition.
The scope has been restricted to heparin material of porcine origin since some
of the latest requirements do not apply to materials of other origins and that
heparin medicinal products currently on the European market are all of porcine
origin. Further to the replacement of the clotting assay by 2 chromogenic
assays for anti-factor IIa activity and anti-factor Xa activity in general
chapter 2.7.5. Assay of heparin, potency is now measured by the assay of
anti-factor IIa activity.
Production.
A statement was introduced during the last revision, which requires testing for
identity of the source species and the absence of material from other likely
cross-contaminant species. Further indications have been added that reflect
current widely spread practices.
Identification:
a requirement for the ratio of anti-factor Xa activity to anti-factor IIa
activity has been introduced; a ratio of 1 is typical of unfractionated
heparin.
Sodium:
range modified in line with current batch data
Sucrose (0204)
Posted by Tim Sandle
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