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Inspection certificate EN 10204 - 3.

Date of delivery Delivery note


11.10.2019 26682462
Requisition No. Date of requisition
PTB-6351/I/19 / 14.02.2019
Order No. Customer No. Fax
8293779 / 000001 / 14.02.2019 90111788 62226031979

Wacker Chemie AG Werk Nünchritz Friedrich-von-Heyden-Platz 1 D-01612 Nünchritz


PT. Brataco
JL.Kelenteng No. 8
0001 BANDUNG
INDONESIA date of issue: 11.10.2019
HDK® N20 PHARMA
HYDROPHILIC PYROGENIC SILICA
Material 60081785 Batch YA47895 NET 160,000 kg Date of 20.08.2019 Best use before 19.08.2022
manufacture end

Technical data Test method/Inspection condition Unit Measured value Lower limit Upper limit
Surface BET DIN 9277/66132 PV09001 m²/g 200 175 225
pH-value in suspense EN ISO 787/9 PV09005 nounit 4,1 3,8 4,3
Sieve residue >40 µm EN ISO 787-18 PV09004 % 0,000 0,000 0,030
Loss on ignition according USP % 0,4 0,0 2,0
Loss on drying according USP % 0,2 0,0 1,5
Assay (Content silicon dioxide) according USP % 100,2 99,0 100,5
Content arsenic (As) according USP/AAS ppm <3 - 3
Content chlorine (Cl) according EP mg/kg < 250 - 250
Identity A and B according USP - positive - -

Test methods are in accordance with the specification requirements for "Colloidal Anhydrous Silica" in the current version of EP and for "Colloidal Silicon Dioxide" in the current version of USP.

This product meets the purity requirements of the monograph "Colloidal Anhydrous Silica" as stated in the current version of the British Pharmacopeia and of the monograph "Colloidal Silicon Dioxide" as stated
in the current version of the Indian Pharmacopeia.

This product meets the purity requirements for E 551 according to the Commission Regulation (EU) No. 231/2012 and for INS 551 according to the current FCC and JECFA monographs.

Wacker Chemie AG, Nünchritz, Germany


This certificate was issued by machine and is valid without a signature.
Business Unit Basics & Intermediates
Quality Control, Dr. M. Niemetz
e-Mail: S-B-Q-QCCofAContact@wacker.com
This data does not absolve the purchaser from checking the quality of all supplies
immediately on receipt, particularly regarding the possible influences of transport Page 1 of 4
and intermediate storage conditions over which we have no control.
All sales of this product shall be subject to our General Conditions of Sale.
Inspection certificate EN 10204 - 3.1

Date of delivery Delivery note


11.10.2019 26682462
Requisition No. Date of requisition
PTB-6351/I/19 / 14.02.2019
Order No. Customer No. Fax
8293779 / 000001 / 14.02.2019 90111788 62226031979

Wacker Chemie AG Werk Nünchritz Friedrich-von-Heyden-Platz 1 D-01612 Nünchritz


PT. Brataco
JL.Kelenteng No. 8
0001 BANDUNG
INDONESIA date of issue: 11.10.2019
HDK® N20 PHARMA
HYDROPHILIC PYROGENIC SILICA

Typical general properties:


Appearance: White, fine, amorphous powder
Odour: Odourless
Solubility: Virtually insoluble in water at 20 °C
Tap density EN/ISO 787/11: approx. 40 g/l

GMO (Genetically Modified Organisms):


This product is not derived from genetically modified organisms and for its manufacture no intermediates and/or auxiliary agents which are genetically modified are used.

BSE/TSE:
This product is not derived from human or animal origin and for its manufacture no intermediates and/or auxiliary agents which are of human or animal origin are used.

Residual solvents:
Solvents as stated in "Guideline for residual solvents (CPMP/ICH/283/95)" of the current version of EP are not used for the manufacture of this product.

This product is manufactured in a dedicated production unit at the site Wacker Chemie AG, Friedrich-von-Heyden-Platz 1, 01612 Nünchritz, Germany.
Production, packaging and quality control comply with the principles of the "IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients". Production, packaging and quality control of this
product are certified according to ISO 9001:2008 and HACCP.

Wacker Chemie AG, Nünchritz, Germany


This certificate was issued by machine and is valid without a signature.
Business Unit Basics & Intermediates
Quality Control, Dr. M. Niemetz
e-Mail: S-B-Q-QCCofAContact@wacker.com
This data does not absolve the purchaser from checking the quality of all supplies
immediately on receipt, particularly regarding the possible influences of transport Page 2 of 4
and intermediate storage conditions over which we have no control.
All sales of this product shall be subject to our General Conditions of Sale.
Inspection certificate EN 10204 - 3.1

Date of delivery Delivery note


11.10.2019 26682462
Requisition No. Date of requisition
PTB-6351/I/19 / 14.02.2019
Order No. Customer No. Fax
8293779 / 000001 / 14.02.2019 90111788 62226031979

Wacker Chemie AG Werk Nünchritz Friedrich-von-Heyden-Platz 1 D-01612 Nünchritz


PT. Brataco
JL.Kelenteng No. 8
0001 BANDUNG
INDONESIA date of issue: 11.10.2019
HDK® N20 PHARMA
HYDROPHILIC PYROGENIC SILICA
Material 60081785 Batch YA47897 NET 3.040,000 kg Date of 20.08.2019 Best use before 19.08.2022
manufacture end

Technical data Test method/Inspection condition Unit Measured value Lower limit Upper limit
Surface BET DIN 9277/66132 PV09001 m²/g 201 175 225
pH-value in suspense EN ISO 787/9 PV09005 nounit 4,1 3,8 4,3
Sieve residue >40 µm EN ISO 787-18 PV09004 % 0,000 0,000 0,030
Loss on ignition according USP % 0,4 0,0 2,0
Loss on drying according USP % 0,1 0,0 1,5
Assay (Content silicon dioxide) according USP % 100,0 99,0 100,5
Content arsenic (As) according USP/AAS ppm <3 - 3
Content chlorine (Cl) according EP mg/kg < 250 - 250
Identity A and B according USP - positive - -

Test methods are in accordance with the specification requirements for "Colloidal Anhydrous Silica" in the current version of EP and for "Colloidal Silicon Dioxide" in the current version of USP.

This product meets the purity requirements of the monograph "Colloidal Anhydrous Silica" as stated in the current version of the British Pharmacopeia and of the monograph "Colloidal Silicon Dioxide" as stated
in the current version of the Indian Pharmacopeia.

This product meets the purity requirements for E 551 according to the Commission Regulation (EU) No. 231/2012 and for INS 551 according to the current FCC and JECFA monographs.

Wacker Chemie AG, Nünchritz, Germany


This certificate was issued by machine and is valid without a signature.
Business Unit Basics & Intermediates
Quality Control, Dr. M. Niemetz
e-Mail: S-B-Q-QCCofAContact@wacker.com
This data does not absolve the purchaser from checking the quality of all supplies
immediately on receipt, particularly regarding the possible influences of transport Page 3 of 4
and intermediate storage conditions over which we have no control.
All sales of this product shall be subject to our General Conditions of Sale.
Inspection certificate EN 10204 - 3.1

Date of delivery Delivery note


11.10.2019 26682462
Requisition No. Date of requisition
PTB-6351/I/19 / 14.02.2019
Order No. Customer No. Fax
8293779 / 000001 / 14.02.2019 90111788 62226031979

Wacker Chemie AG Werk Nünchritz Friedrich-von-Heyden-Platz 1 D-01612 Nünchritz


PT. Brataco
JL.Kelenteng No. 8
0001 BANDUNG
INDONESIA date of issue: 11.10.2019
HDK® N20 PHARMA
HYDROPHILIC PYROGENIC SILICA

Typical general properties:


Appearance: White, fine, amorphous powder
Odour: Odourless
Solubility: Virtually insoluble in water at 20 °C
Tap density EN/ISO 787/11: approx. 40 g/l

GMO (Genetically Modified Organisms):


This product is not derived from genetically modified organisms and for its manufacture no intermediates and/or auxiliary agents which are genetically modified are used.

BSE/TSE:
This product is not derived from human or animal origin and for its manufacture no intermediates and/or auxiliary agents which are of human or animal origin are used.

Residual solvents:
Solvents as stated in "Guideline for residual solvents (CPMP/ICH/283/95)" of the current version of EP are not used for the manufacture of this product.

This product is manufactured in a dedicated production unit at the site Wacker Chemie AG, Friedrich-von-Heyden-Platz 1, 01612 Nünchritz, Germany.
Production, packaging and quality control comply with the principles of the "IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients". Production, packaging and quality control of this
product are certified according to ISO 9001:2008 and HACCP.

Wacker Chemie AG, Nünchritz, Germany


This certificate was issued by machine and is valid without a signature.
Business Unit Basics & Intermediates
Quality Control, Dr. M. Niemetz
e-Mail: S-B-Q-QCCofAContact@wacker.com
This data does not absolve the purchaser from checking the quality of all supplies
immediately on receipt, particularly regarding the possible influences of transport Page 4 of 4
and intermediate storage conditions over which we have no control.
All sales of this product shall be subject to our General Conditions of Sale.

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