Product information
Revision Number: 2
Date of Revision: 15 March 2019
Document Ref: a3077
To whom it may concern
Statement regarding Elemental Impurities
Arlacel 165 FP-PA-(RB) CB07312
SP Arlacel 165-FP MBAL-PA-(RB) CB02890
Croda Europe Ltd can advise that for the above named products the following information
and evaluation is provided in relation to the ICH Q3D Elemental Impurities Guideline.
Three batches of SP Arlacel 165-FP MBAL-PA-(RB) CB02890 were sampled and analysed
for the following elements. Results are given below. These can be used as read across for
Arlacel 165 FP-PA-(RB) CB07312.
Element Batch 1 Batch 2 Batch 3
(ppm w/w) (ppm w/w) (ppm w/w)
Ag <0.45 0.21 <0.13
As <0.08 <0.13 <0.2
Au <0.29 <0.02 <0.29
Bi <0.11 <0.15 <0.14
Cd <0.02 <0.11 <0.03
Co <0.03 <0.07 <0.02
Cr <0.03 <0.11 <0.07
Cu <0.03 <0.3 0.08
Hg <0.1 <0.05 <0.05
Mo <0.04 <0.08 <0.05
Ni 0.30 0.24 <0.3
Pb <0.08 <0.08 <0.08
Pd <0.19 <0.26 <0.25
Pt <0.51 <0.62 0.18
Ru <0.1 <0.07 <0.08
Sb <0.27 <0.13 <0.09
Sn 0. 14 0.14 <0.11
V <0.08 <0.11 <0.02
Os 0.18 <0.18 <0.09
Rh <0.3 <0.42 <0.47
Ir <0.21 <0.09 <0.02
Ba <0.01 <0.14 0.03
Li <0.01 <0.1 0.00
Se 0.31 <0.55 <0.46
Tl <0.06 <0.11 <0.16
Non-warranty
This information provided is based on our current knowledge and relates to the standard specification (00). It is provided exclusively to you in good faith for your guidance and general information only and solely
for the purpose for which you intended it to be provided. This information does not constitute any form of specification agreement and no additional representation or warranty is made as to its completeness,
accuracy or fitness for a particular purpose. Furthermore, it does not relieve our customers from the obligation to perform a full inspection of any product upon delivery or any other obligation. There is no
automatic updating of these correspondences. Unless we provide express, prior, written consent, no part of this report should be reproduced, distributed or communicated to any third party.
Croda Europe Ltd, Product Assurance Department, Cowick Hall, Snaith, Goole, East Yorkshire, DN14 9AA
Tel ++44 1405 860551 Fax ++44 1405 861767
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These elements are not routinely analysed unless limits appear on the specification.
Croda Europe Ltd can confirm that elementary impurities are not intentionally added to the
above named product(s).
Croda has a policy that a Certificate of Analysis only shows test results for analyses
conducted on that batch. Therefore we are unable to include general statements of
compliance to EMA/CHMP/ICH/353369/2013 or ICH Q3D on the Certificate of Analysis.
The ICH Q3D guideline is not a compliance limit for excipients.
Shameem Akhtar
Lead Product Assurance Coordinator
Non-warranty
This information provided is based on our current knowledge and relates to the standard specification (00). It is provided exclusively to you in good faith for your gui dance and general information only and solely
for the purpose for which you intended it to be provided. This information does not constitute any form of specification agreement and no additional representation or warranty is made as to its completeness,
accuracy or fitness for a particular purpose. Furthermore, it does not relieve our customers from the obligation to perform a full inspection of any product upon delivery or any other obligation. There is no
automatic updating of these correspondences. Unless we provide express, prior, written consent, no part of this report should be reproduced, distributed or communicated to any third party.
Croda Europe Ltd, Product Assurance Department, Cowick Hall, Snaith, Goole, East Yorkshire, DN14 9AA
Tel ++44 1405 860551 Fax ++44 1405 861767
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