Download Rhodiola rosea radix Rose root

Technical Data Sheet – Herbal Information
Rhodiola rosea radix
Rose root
Item-D: 04-002-1046-00
Definition
Botanical name
Rhodiola rosea
Used part
the dried cut roots
Characters
Colour
red to brown
Identity
Method
Requirements
Macroscopic
AE-method
complies with the requirements
Microscopic
AE-method
complies with the requirements
Thin-layer chromatography
AE-method
complies with the requirements
Purity
Method
Requirements
Foreign matter
Ph. Eur. 2.8.2
NMT 2 %
Loss on drying
Ph. Eur. 2.2.32
NMT 12.0 %
Total ash
Ph. Eur. 2.4.16
NMT 12.0 %
Special impurities:
Pesticide residues, heavy metals, aflatoxins and microbiology are in accordance with the current
regulations
Assay
Method
Requirements
Salidrosid
HPLC-AE-Method
batch specific control, calc. on dried
drug
Total rosavin
HPLC-AE-Method
batch specific control, calc. on dried
drug
Storage conditions
Closed safely, protected from light, high temperature and under pest control
Created
Reviewed and released:
Carsten Rittweger
Dr. Astrid Nagell
[Quality Control]
[Ldr. QC / QM]
………………………………………………………………………………………………………………
Signature
…………………………………………………………………………………………………………….
Signature
Date of release
06-11-2012
………………………………………….
Version: 00
Page 1 of 1
© Anklam Extrakt GmbH; Johann-Friedrich-Böttger Straße 4; D-17389 Anklam; Tel.: (+49) 3971-24-11-010; email: [email protected] ; www.anklam-extrakt.com
Technical Data Sheet – Product Information
Rhodiola e rad. extr. spir. sicc.
Rose root ethanolic dry extract
Item-D: 00-115-1046-01
Definition
Aqueous – alcoholic dry extract obtained from Rhodiola rosea radix.
Used plant material
Botanical name
Rhodiola rosea
Botanical part used
the dried cut roots
Identity
complies with the requirements in AE-monograph
Manufacturing dates
Requirements
Extraction solvent
Ethanol 70 % (V/V)
DER native
4 to 7 : 1
Characters
Method
Requirements
Appearance
visual
red to reddish brown powder
Identification
Method
Requirements
Thin layer chromatography
AE-method
complies with standard TLC
Assay
Method
Requirements
Salidrosid
HPLC-AE-Method
batch specific control (dried drug)
Total rosavin
HPLC-AE-Method
batch specific control (dried drug)
Purity
Method
Requirements
Loss on drying
Ph. Eur. 2.8.17
NMT
Residue solvent Ethanol
Ph. Eur. 2.9.10
NMT 0.5 %
5%
Special impurities:
Pesticide residues, heavy metals, aflatoxins and microbiology are in accordance with the current
regulations
Storage conditions
Closed safely, protected from light, humidity, heat and under pest control.
Created
Reviewed and released:
Carsten Rittweger
Dr. Astrid Nagell
[Quality Control]
[Ldr. QC / QM)]
………………………………………………………………………………………………………………
Signature
…………………………………………………………………………………………………………….
Signature
Date of release:
06-11-2012
………………………………………….
Version: 00
Page 1 of 1
© Anklam Extrakt GmbH; Johann-Friedrich-Böttger Straße 4; D-17389 Anklam; Tel.: (+49) 3971-24-11-010; email: [email protected] ; www.anklam-extrakt.com