PRODUCT SPECIFICATIONS
ACETAMINOPHEN / PARACETAMOL
APPEARANCE
White, free-flowing granular powder
IDENTIFICATION
(A) APAP/Paracetamol: Matches
reference standard
(B) Starch: Blue or blue-violet color
FREE p-AMINOPHENOL
0.0045% Max
SULPHATED ASH 0.2% Max
HEAVY METALS
0.001% Max
WATER (H2O)
0.25%-0.85%
PARTICAL SIZE BY SIEVE
TEST
(Cumulative % Retained)
No. 100: 20% Min
No. 270: 70% Min
Report % Found
ASSAY (APAP) (AS IS BASIS)
93.0 – 96.0%
MICROBIOLOGICAL
TOTAL VIABLE MICROBIAL COUNT
100 cfu/g Max
YEAST AND MOLD
100 cfu/g Max
SALMONELLA
Negative
ESCHERICHIA COLI
Negative
STAPHYLOCOCCUS AUREAS
Negative
PSEUDOMONAS AERUGINOSA
Negative
Paracetamol DC 273N (P.G.S.)
(Paracetamol Ph Eur; USP 95%
Anhydrous Basis) ITEM CODE 4255
PARACETAMOL DC 273N (P.G.S.) is a directly
compressible form of Acetaminophen. It is not fully
formulated meaning that this compressible
Acetaminophen form is to be blended with other
pharmaceutical excipients and lubricants prior to
tableting to realize the customer’s desired tablet
dissolution, friability and tableting characteristics.
Paracetamol DC 273N (P.G.S.) is manufactured using
exclusively Mallinckrodt Acetaminophen USP/Ph.Eur.
(94.5%) and pharmaceutical grade pregelatinized starch
(5.0%) and povidone (0.5%) also meeting Ph. Eur.
criteria. This composition has been specially processed
to yield a product with excellent flow properties,
compression characteristics and a unique particle size
distribution. This particle size distribution resulting from
our spray drying process, is finer in profile than what
would result from a classic wet granulation process.
The Paracetamol DC 273N (P.G.S.) particle size profile
as a result is appropriate for readily accomplishing
homogeneous blends of this directly compressible
form of Acetaminophen with other actives as well as
the excipients necessary to carry the added active
pharmaceuticals. A European DMF is maintained on
Paracetamol DC 273N (P.G.S.).
The information printed herein is derived from our own laboratories and other sources, and is believed to
be accurate. However, it may be modified by later findings and should be used with this understanding.
Nothing herein shall be construed as a recommendation to use any product in violation of any patent
rights. The user shall have sole responsibility for determination of whether this product is suitable for any
particular purpose. Prior to use, refer to the Material Safety Data Sheet for assistance in determining
safe handling, storage, and use procedures.
Effective 3/2014