Product Specification

Product Name: DOXAZOSIN MESYLATE HETERO

(Hetero Drugs Limited, India)

Doxazosin mesilate
Spezifikation: DOX_12215610_AL Version: 7

Grade: INTERNAL

22
Status: Approved Effective Date: 09.10.2019

reviewed by QC Bager Florian 07.10.2019 08:21

0
approved by QP / FvPde la Vigne Claudine 09.10.2019 11:06

-2
Assigned to SAP Materials:

12215610 DOXAZOSIN MESYLATE HETERO

G
Test item Reference Specification

Residual solvents (extern) (GC, UIH AM 0631)

U
Methanol
-A
≤ 1'000 ppm
Acetone
≤ 1'000 ppm
08

n-Butanol
≤ 1'000 ppm

Alkyl sulfonate (extern) (GC/MS, UIH AM 0698)

Methyl methanesulfonate
≤ 10 ppm
on

Ethyl methanesulfonate
≤ 10 ppm
Isopropyl methanesulfonate
≤ 10 ppm
Raw material: Certificate of (own monograph)
manufacturer
d

Must comply to the reference certificate of

te

manufacturer
Appearance (own monograph)
White or almost white, crystalline powder
in

Solubility (Ph. Eur.)

Must comply
Pr

Identification A: (Ph. Eur. 2.2.24)

IR-spectrum
Identification B:
X-ray diffraction
Must comply to the spectrum of the
reference
V_52_DOK_S393_01 (USP
<941>)
Must comply to the reference

Print Date: 11.10.2019 12:34:40 Page 1 of 4

Acino Pharma AG | Dornacherstrasse 114 | 4147 Aesch | Switzerland

 Product Specification

Product Name: DOXAZOSIN MESYLATE HETERO

(Hetero Drugs Limited, India)

Doxazosin mesilate
Spezifikation: DOX_12215610_AL Version: 7

Grade: INTERNAL

Status: Approved Effective Date: 09.10.2019

22
Test item Reference Specification

0
Identification: NIR-spectrum (own monograph)
Must comply to the spectrum of Class

-2
Doxazosin mesylate
Appearance of solution (Ph. Eur. 2.2.1 and 2.2.2)
Clear and not more intensely coloured

G
than reference solution BY6
Related substances (HPLC, Ph. Eur. 2.2.29)
Each unspecified impurity Reporting Threshold: 0.05

U
≤ 0.10 %

Related substances
-A
(HPLC, Ph. Eur. 2.2.29)
Total impurities Reporting Threshold: 0.05
≤ 0.3 %
08
Water (Ph. Eur. 2.5.12)
≤ 1.5 %

Sulfated ash (Ph. Eur. 2.4.14)

≤ 0.1 %
on

Assay of Doxazosin mesilate (HPLC, Ph. Eur. 2.2.29)

98.0 - 102.0 %

(calculated on dried substance)

d

Heavy metals (Ph. Eur. 2.4.8,

method C)
te

≤ 10 ppm
Melting point (DSC) (own monograph)
in

273 - 280 °C

Residual solvents (GC, UIH AM 0631)

Methanol
Pr

≤ 1'000 ppm
Acetone
≤ 1'000 ppm
n-Butanol
≤ 1'000 ppm

Print Date: 11.10.2019 12:34:40 Page 2 of 4

Acino Pharma AG | Dornacherstrasse 114 | 4147 Aesch | Switzerland

 Product Specification

Product Name: DOXAZOSIN MESYLATE HETERO

(Hetero Drugs Limited, India)

Doxazosin mesilate
Spezifikation: DOX_12215610_AL Version: 7

Grade: INTERNAL

Status: Approved Effective Date: 09.10.2019

22
Test item Reference Specification

0
Particle size (lazer diffraction,
own monograph)

-2
10 %
≤ 5 µm
50 %
≤ 10 µm

G
90 %
≤ 25 µm
Alkylsulfonate (GC/MS, UIH AM 0698)

U
Methyl methanesulfonate
≤ 10 ppm
Ethyl methanesulfonate
-A
≤ 10 ppm
Isopropyl methanesulfonate
≤ 10 ppm
08

Microbiological purity (Ph. Eur. 5.1.4)

Microbiological quality of non-sterile
pharmaceutical preparations and
substances for pharmaceutical use.
Substances for pharmaceutical use. Total
on

aerobic microbial count not more than 10³

CFU and total yeasts / moulds count not
more than 10² CFU per g or ml. Absence
of Escherichia coli (1 g or 1 ml), (2.6.12
and 2.6.13).
Microbiological purity (extern) (Ph. Eur. 5.1.4)
d

Microbiological quality of non-sterile

pharmaceutical preparations and
te

substances for pharmaceutical use.

Substances for pharmaceutical use. Total
aerobic microbial count not more than 10³
in

CFU and total yeasts / moulds count not

more than 10² CFU per g or ml. Absence
of Escherichia coli (1 g or 1 ml), (2.6.12
and 2.6.13).
Pr

Identification B: V_52_DOK_S393_01 (USP

X-ray diffraction (extern) <941>)
Must comply to the reference
Melting point (DSC) (extern) (own monograph)
273 - 280 °C

Print Date: 11.10.2019 12:34:40 Page 3 of 4

Acino Pharma AG | Dornacherstrasse 114 | 4147 Aesch | Switzerland

 Product Specification

Product Name: DOXAZOSIN MESYLATE HETERO

(Hetero Drugs Limited, India)

Doxazosin mesilate
Spezifikation: DOX_12215610_AL Version: 7

Grade: INTERNAL

Status: Approved Effective Date: 09.10.2019

22
Microbiological purity, Residual solvents: tested once a year

0
Product History:

-2
Version 1:
first version in LabWare LIMS
Version 2:

G
layout and testing categories modifications
replaces WinLIMS PP-Nr.: 224 / PP-Vers.: 6
Addition of Analysis: "Identification: NIR-spectrum"

U
for comparison of packages
18.11.2016 (MMAI01)
-A
Version 3: Registration Grade without NIR added
Addition of Particle size "10 % ≤ 5 µm" according
Dossier 3.2.S.4.1
Additionally the test parameter "Particle size" will transfer from
08

manufacturer`s certificate
03.04.2018 (MMAI01)
Version 4: Adaptation to Dossier: Removal of test parameter
"Alkylsulfonate" and "Microbiological purity" in Registration Grade
11.04.2018 (MMAI01)
on

Version 5: Referenz zur validierten ID B Methode eingefügt.

Version 6: Update Water nach aktueller Ph.Eur. 2.5.12; Prüfpunkt
Solubility aufgenommen
Version 7: Genaue Methodenbezeichnung in die Analysen Residual
solvents und Alkyl sulfonate eingefügt.
d
te
in
Pr

Print Date: 11.10.2019 12:34:40 Page 4 of 4

Acino Pharma AG | Dornacherstrasse 114 | 4147 Aesch | Switzerland

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