PHARMA

GMP ICH Q7

esco
Ph. Eur., USP, JP
CEP Certificate
FDA registered
API-NaCl
Sodium chloride in pharmacopoeia quality pyrogen-free

Field of application

esco API-NaCl is an active pharmaceutical ingredi- Pyrogen-free

ent and ideal for use in solutions for enteral and (free from bacterial endotoxins)
parenteral infusion, peritoneal dialysis and for
other pharmaceutical uses. High purity

Product properties Of natural origin

To satisfy the extremely strict requirements in Low content of by-minerals

pharmaceutical manufacturing processes, esco
european salt company produces a particularly
pure pharmaceutical-grade salt that exceeds the
purity requirements set out in various pharma-
copoeias. esco API-NaCl is made from premium-
quality sodium chloride, offers exceptional chem-
ical purity and contains absolutely no additives.
 PHARMA

esco
API-NaCl
Sodium chloride in pharmacopoeia quality pyrogen-free

Product range aged and stored separately from federal regulatory authorities
all other salt production equip- Traceability system thanks to

Packaging size: 25 kg bag
(40 x 25 kg/
ment in dedicated areas. unique labelling
IPPC pallet) Accompanying HACCP analyses
900-1,000 kg and quality management that Production process
single-use FIBC/
Big Bag accommodates the requirements
Type of packaging: 25 kg of EN ISO 9001 and the regula- esco API-NaCl is obtained from
Pharma bag tions of the EC GMP and ICH Q7 particularly pure brine through
(multi-layer
Guidelines safeguard our exact- a highly sophisticated vacuum
paper bag with
PE coating) ing quality standards. salt method. All stages of the
900-1,000 kg production, analysis and qual-
single-use FIBC/
Big Bag with Product quality ity control process comply with
inliner the strict basic rules of the
GTIN: 25kg: Produced in accordance with
GMP. With this precise produc-
4003885381116
the EC GMP Guidelines and tion process, we guarantee our
We would be happy to provide you ICH Q7 customers maximum reliability
with a sample.
Complies with the require-
and safety for products based
For more information on this and
other products, please do not hesitate
ments of the European on API-NaCl.
to contact us. (Ph. Eur.), American (USP) and
Japanese (JP) pharmacopoeias The company
CEP certificate

FDA registered
esco european salt company
Quality management system
is the leading salt producer
Analysis according to EN ISO 9001 for international pharmaceuti-
HACCP product safety system
cal companies in Europe and
esco API-NaCl is produced in in accordance with the princi- exports significant quantities
individual batches and then ples of the Codex Alimentarius overseas. With two state-of-the-
analyzed. An individual analysis Regular audits of production
art facilities in Europe, we are
certificate is provided with each facilities by experts, pharma able to guarantee our custom-
delivery. esco API-NaCl is pack- ceutical companies and ers reliable deliveries.

esco european salt company GmbH & Co. KG

Landschaftstrae 1 Phone: +49 511 85030-0 info@esco-salt.com A K+S Group company
30159 Hannover, Germany Fax: +49 511 85030-131 www.esco-salt.com Version 2.0