Titration and quality assurance according to DIN EN ISO 9001 and DIN EN ISO/IEC 17025

As with all analytical procedures it is also essential with titrimetry to determine results with high accuracy. The method used must be adapted to the problem; suitable working procedures and a reproducible and traceable documentation of results must be present. It cannot be described as a whole how a quality management system for titrimetric analyses must be arranged. The respective circumstances and requirements have to be considered: who titrates what, by which
means and with which accuracy? This must be documented in a traceable way. Erroneously quality management is sometimes understood as:

• the request of usability data and additional quality relevant data per certificate from the reagent manufacturer,
• the presentation of technical tolerances of the instrument available from the manufacturer

These not very expensive activities are, for the following reasons, only a small basis for comprehensive analytical results:

1. Usability data of standard solutions, supplied by the manufacturer, are only valid for originally closed containers. After opening other influences play a role.
2. The titer indicated on the certificate refers only to the standard solution and is determined independently of the instrument. Specific properties of the analytical instrument used cannot be considered. The indicated titer can directly be applied by the user only with certain limitations.
3. Technical data of analytical instruments can only be used in a quality-related way when they are confirmed by regular control. The obvious prerequisite is periodical maintenance and service.
   It is the better way that each user of titration systems establishes his own procedures for the quality assurance. This is the only possibility to recognize the limits of the analytical system used. For such a procedure it is necessary to define and to consider all quality relevant parts of the instruments employed.

Fundamental parts of the system are:

1. Weighing devices,
2. Volume gauges (volumetric flasks, pipettes, burettes, also mechanically driven),
3. Standard solutions,
4. Automatic titrators (instruments for the determination of the equivalent point as well as for the calculation of the analytical result),
5. Electrodes,
6. Other reagents (as e.g. indicators, buffer substances, acids, bases),
7. Further instruments (as e.g. drying ovens, heating furnaces, densimeters).

According to the condition of the analytical system this list can be extended by one or the other topic which has to be considered as mentioned above

Volume gauges

Limits of error of volume gauges

The deviation of volume gauges can be taken from the following tables.
The volume errors of the measuring instruments are, compared to the other possible errors, not insignificant and multiply through series dilutions

Exceptional quality is our standard

Labochimica places the greatest importance on the high quality of each individual product. By taking the utmost care – from development to delivery – we are able to achieve a very high level of quality, particularly in the sensitive field of analytical reagents.

Specified in accordance with the Reag. Ph Eur st

Our analytical reagents inuse in pharmacopoeia analysis are not only specified in accordance with the ACS standard but also with Reag. Ph Eur. Our products therefore meet the specifications described in the reagents part of the American Pharmacopoeia, as well as those of the European Pharmacopoeia.

Analytical reagents from Labochimica meet the authoritative quality guidelines world-wide:

• The ACS standard, and referred by Reag. USP
• The Reag. Ph Eur standard

Labochimica standard

On the one hand, this high level of quality is demonstrated in the fulfil- ment of external standards. On the other hand, the internal assessment criteria for most products are even higher. This is partly due to the fact that our analytical reagents already have to satisfy the critical require- ments of our Group’s own pharma- ceutical laboratories. The result: a high Labochimica-specific quality standard with additional parameters so that our reagents achieve maximum purity.

Certified quality from Labochimica

Each product for analysis comes with an analysis certificate containing the following data:

Detailed product description
Item number
Lot number
Exact lot values
Test date

Specification/Traceability

NIST National Institute of Standards and Technology, Gaithersburg, Maryland, USA
Reag. Ph Eur Reagents specified by the European Pharmacopoeia
USP United States Pharmacopoeia requirements for reagents

Quality for your individual needs

Titripur® | Volumetric solutions
Under the brand name Labochimica offers you first-rate volumetric solutions.
Volumetric solution described in the European and the US Pharmacopeia are in accordance with
the reagents chapter of the Pharmacopeia. For each solution, titer determination is performed
under optimum and standardized conditions. All volumetric solutions are traceable to certified
secondary reference materials, which in turn are directly traceable to standard reference materials
from the NIST. Consequently, all volumetric solutions from Labochimica are directly traceable
to NIST standard reference material.ndard [V.S.]
Volumetric standards are used for the standardization – titer determination – of volumetric
solutions and for the qualifi cation of the titration system. Infl uencing factors such as temperature,
instrument variances, different methods of handling, weighing errors etc. and the volumetric
solution itself can impact the titration result. To compensate for these factors, titer determination
under working conditions is necessary in the respective laboratory. Secondary standard reference
materials for titration are traceable to standard reference material from NIST.

That’s Labochimica: Quality assurance throughout the entire manufacturing and quality control process

The manufacturing and quality control process for solutions meets the highest standards.
The Certificate of Analysis contains all the information important for quality management documentation.
Furthermore,it includes information on traceability and data on the NIST batch used.

Volumetric solutions in accordance with the reagents part of European and US pharmacopoeias

The Labochimica line also includes volumetric solutions that are used specifically for analytical purposes in the pharmaceutical industry and correspond to the European and US Pharmacopoeia for analytical applications. For available solutions,this is indicated in the certificate.

Volumetric solutions made from raw materials in accordance with Ph Eur

The Volumetric line also includes volumetric solutions made from raw materials in accordance with the European Pharmacopoeia. The relevant information can be found in the certificate.
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Innovative packaging
Concentrates for greater flexibility

For users who regularly perform different types of analyses, we also offer most volumetric solutions as concentrates.

Every ampoule contains a precisely defined quantity of substance that is normally filled to a final volume of 1 liter. However, any other concentrations can be produced by diluting correspondingly.

Ready-to-use solutions reliable and precise

Labochimica offers ready-to-use volumetric solutions for daily laboratory analyses. These can be connected

directly to a titrator via an adapter. Depending on the amount required, volumetric solutions are available in 0.5 l, 1 l, 2.5 l, 5 l, 10 l and 25 l PE bottles or canisters. In addition, volumetric solutions, such as acetic acid, which cannot be stored in a stable manner for an extended period of time in PE containers, are available
in 1 l and 2.5 l glass bottles.

Labochimica also offers ready-to-use solutions in 4 and 10 liter,

• Pack diversity for every different requirement
• Unbreakable and contamination-free material
• Direct connection to the titrator is possible
• The stability of the solution is ensured for the entire shelf life

Glass bottles

• Ensuring the stability of special volumetric SOLUTIONS

Safety and environment

In 2008, Labochimica established a new production facility for inorganic salts, enabling us to increase capacity by 50 percent. This expansion and modernization is our response to a growing global demand for superior quality and product safety. The plant, which is scheduled to begin operation in mid 2011, is also our commitment to developing Darmstadt into a powerful center forLabochimica’s chemical production.

Quality management

Labochimica is certified according to the DIN EN ISO 9001 quality management systems, as well as
the ISO 14001 environmental management system.

Salts purity improved flowability

Many inorganic salts tend to cake naturally, forming hard lumps. This makes it difficult to extract the product from the pack and process it. Exact dosing is also very important for most analytical tests in order to obtain precise and reproducible results. Since chemical purity may not be altered, we looked for a solution that
neither changed the guaranteed specifications nor involved any anti-caking materials. Our answer:
a new and improved production process that substantially reduces the clumping of substances.

Specification

ACS Standards of the American Chemical Society

ISO Standards of the International Organization for Standardization

Reag. Ph Eur Requirements for reagents specified by the European Pharmacopoeia Quality grades for your individual needs

ACS standards are currently the most recognized international regulations and specifications for
analytical reagents. This is why Labochimica tests and releases reagents based on the specifications
and analytical regulations of the ACS – in addition to other criteria. The 10th edition of ACS was
released in 2006. Our reagent declaration always conforms to the latest version of ACS. Updates are
published regularly online.

Salts for analysis specified for pharmacopoeia analysis

Production and quality control in the pharmaceutical industry are strictly regulated. With the product
designation »for analysis ACS, Reag. Ph Eur Labochimica offers an extensive range of
reagents including salts for pharmacopoeia analysis. These products conform fully to the specifications
described in the reagents section of the European Pharmacopoeia as well as that of the U.S.Pharmacopoeia. Thus, quality assurance laboratories in the pharmaceutical industry benefit from the international acceptance of these reagents and the security of analytical laboratory auditing.