About Us

Karpschem is ISO 9001:2015 & WHO-GMP certified independent reliable R&D based custom
manufacturing company
Registered on 1st December 2021 under Ministry of Commerce, Govt. of India
Start-up company approved by UDYUM AADHAR, Govt. of India
Deals in Products & Services to Pharma, Agrochemicals & Speciality chemical industries
Custom Technology / Process Development and Technology transfer services
Provides analytical services with analytical data interpretation support

Quality Management System

Quality planning: At Karpschem, quality is part of each and every step. Planning focuses on all areas of
operation comprising procurement of the raw materials, to synthesis, then Storage and precise delivery
as per customer's requirements.
Quality assurance: Karpschem’s Quality Assurance Department, constantly monitors and appraises the
service as per SOP’s to ensure requirements for Quality are being satisfied.
Quality control: Karpschem embraces, a full-fledged Quality Control Laboratory, which follows and
integrates up-to-date, contemporary, and high-tech testing equipment, in order to perform the stringent
quality analytical tests like HPLC/GC, Mass Spectroscopy, IR Spectroscopy, Thermal Gravimetric Analysis
(TGA).
Quality improvement: Karpschem is dedicated and committed to delivering value and satisfaction by
improving and maintaining the Quality Management System through meeting specific needs, training to
an individual, CAPA, Clean Work Environment.
Document Control: At Karpschem, Document and Data are maintained to control all documents that
form part of its management system, internally generated or from external sources, including SOP’s with
master and Controlled Copy, Test and Calibration Records, Soft copy of Data on Server.
Audit Management: Karpschem conducts periodic self-assessments through a voluntary self-audit of its
operations, in order to remain internationally competitive, and maintaining an effective Quality
Management System.
CAPA Management: At Karpschem, we Follow CAPA management for any Discrepancies and Audit
Findings. It assures the tracking and trending of issues requiring mid-term and long-term corrective
actions
Quality and Purity Assessment
At Karpschem, we Qualify the Synthesized compounds for Identification / structure elucidation and
Qualification by HNMR and 13C-NMR, MASS, IR Spectroscopy, CHNS and Purity by HPLC/GC/Chemical
Analysis. Purity/Potency is defined by Mass Balance Method using Chromatographic purity and TGA
Data, For Volatile Compounds Ash Content is performed.
After Qualification, product is sent into Global Warehouse. Inventory Team Checks the product for
Quality, from Description to all Characterized Data and approves the qualification Report with
interpretation of all Data.
Once the Material is Qualified and Approved, it is taken into Approved Area and made available for
Dispatching.
Before Dispatch, the material is again Reviewed and Checked by Dispatch QA. Once the Dispatch QA
approves the Quality and Documents as per Specification, it is ready to Dispatch.

Packaging
At Karpschem, we follow 3-layered packaging System:
• For Primary Packing of All CRS, we use high Quality Glass Vials or Storage Vials. For hygroscopic and
sensitive products, the vials are purged with Nitrogen or Argon.
• These Vials are packed in a Secondary Protective HDPE Bottle.
• These Vials are packed in Thermocol Boxes.
• The Thermocol Box is packed in a strong protective outer carton.
• Special Packing and Special Shipping at -20°C can be done for highly sensitive materials.
PHARMACOPEIA TRACEABLE IMPURITIES OF API NEWLY INDUCTED

LUROSIDONE

APIXABAN

TENILAGLIPTIN

ZONISAMIDE

TOFACITINIB

ARIPIPARAZOLE

ATOMOXETINE

SITAGLIPTIN

BREXPIPARAZOLE

VILDAGLIPTIN

ETOROCOXIB

CHLORTHALIDONE

CLOPEDOGREL

CINACALCET

BUMETANIDE

NEW CRAMS ALSO AVAILABLE AS PER REQUIMENT