BRAND GMBH + CO KG

P.O. Box 1155

97861 Wertheim (Germany)
www.brand.de

BRAND GMBH + CO KG ⋅ Otto-Schott-Straße 25 ⋅ 97877 Wertheim ⋅ Germany

PRODUCT INFORMATION
Volumetric instruments according to USP tolerances

Companies producing pharmaceutical products for the USA market and therefore supervised by US
authorities, e.g., the FDA (Food and Drug Administration) have to meet the requirements of the
USP (United States Pharmacopeia).

The USP describes in section 31 the requirements for glass volumetric instruments. In a footnote it
referrers to the N.B.S. Circular (National Bureau of Standards) 602, Issued April 1, 1959.

This NBS Circular 602 gives detailed design specifications and defines tolerances.

Some details are:

1. Each instrument should be marked permanently by an individual identification number.
2. In general, the USP-tolerances are smaller than the DIN specifications of class A/AS.
3. For volumetric flasks the internal neck diameter should be equal to the inner lower diameter of
the ground joint.
4. For bulb pipettes (Transfer Pipets), measuring pipettes and burettes delivery times of class A
are required.
5. The NBS describes volumetric flasks and measuring cylinders calibrated of >Ex< and >In< with
different tolerances.
6. Burettes with Schellbach stripe are not accepted because of potential errors from parallax.

Discussion of USP requirements:

BRAND volumetric instruments are based on the DIN- and/ or ISO-standards and do not meet all
details in construction as mentioned in the USP requirements (NBS circular), which further on are
based on the ASTM standards (American Society for Testing and Materials). Anyway, some of
these regulations turn out not to be relevant in practice since in the first place it is most important to
work according to the demanded tolerances to gain correct and reliable measuring results.

Requirement of an identification number

This requirement is fully accomplished by BRAND volumetric instruments with batch respectively
individual certificate, which additionally even allow determining the year of production by the serial
number.

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BRAND GMBH + CO KG
P.O. Box 1155
97861 Wertheim (Germany)
www.brand.de

Requirements regarding delivery times

At the time the NBS Circular 602 (1. April 1959) was published, class AS volumetric instruments
with short delivery times were not known. BRAND for instance established class AS instruments for
the first time in 1964. (A comfortable advantage of class AS pipettes is the enlarged tip opening
which is effortlessly to clean and does not become blocked easily.) To comply with the stated
tolerances it’s necessary to keep to the specified waiting time. Delivery time and the following
waiting time must be seen as an inseparable unit.
As the NBS Circular 602 presently is still in effect unchanged, class AS instruments are neither in
the NBS Circular nor in the USP mentioned up to now.

Tolerances requirements
For working practice the most important key parameter of volumetric instruments is the tolerance.
Compared to class A/AS the USP tolerances are slightly narrower for volumetric flasks, narrower
for small-volume bulb pipettes and considerably smaller for measuring cylinders.
The USP Certificates for BLAUBRAND® volumetric instruments issued by BRAND confirm the
compliance with USP tolerances.

Other requirements
The requirement, that the internal neck diameter of volumetric flasks should be equal to the inner
lower diameter of the ground joint obviously applies to the uncommon type of volumetric flask which
is calibrated to deliver (>EX<).
The statement of a potentially higher error in reading off burettes with Schellbach stripe is barley
reasonable and not sustainable.

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BRAND GMBH + CO KG
P.O. Box 1155
97861 Wertheim (Germany)
www.brand.de

BLAUBRAND® volumetric instruments with USP certificate

Every glass volumetric measuring instrument is individually calibrated. Computer-controlled systems

ensure maximum precision in a fully automated production line. The final step of this Statistical
Process Control (SPC) is random finished product sampling according to DIN ISO 3951. The
quality management system applied at BRAND and certified to DIN EN ISO 9001 is a combination
of process monitoring and random checks. The accepted quality level is at the very least 0.4.

USP Batch certificate for volumetric flasks only*

Each volumetric flask is supplied with one batch certificate per packing of the manufacturer
confirming the volume tolerances in compliance with the United States Pharmacopeia (USP 27).
The certificate records the mean volume, the standard deviation of the batch and the date of issue
(batch number: year of manufacture/batch).

USP Individual certificate for all volumetric instruments*

The Volumetric measuring instrument is supplied with an individual certificate confirming the volume
tolerance in compliance with the United States Pharmacopeia (USP 27). The certificate records the
measured volume, the uncertainty of measurement and the date of issue (individual serial number:
year of manufacture/batch/consecutive instrument number).

* USP certificates can not be provided for wide neck volumetric flasks.

Appendix: Table of tolerances

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BRAND GMBH + CO KG
P.O. Box 1155
97861 Wertheim (Germany)
www.brand.de

In s t r u m e n t V o lu m e T o l. A / A S T o l. A / A S
D IN 1 2 6 9 1 BBR - USP - E
O n e - M a r k - P ip e tte 0 ,5 m l ± 0 ,0 0 5 m l ± 0 ,0 0 6 m l
O n e - M a r k - P ip e tte 1 ml ± 0 ,0 0 8 m l ± 0 ,0 0 6 m l
O n e - M a r k - P ip e tte 2 ml ± 0 ,0 1 m l ± 0 ,0 0 6 m l
O n e - M a r k - P ip e tte 5 ml ± 0 ,0 1 5 m l ± 0 ,0 1 m l
O n e - M a r k - P ip e tte 10 m l ± 0 ,0 2 m l ± 0 ,0 2 m l
O n e - M a r k - P ip e tte 20 m l ± 0 ,0 3 m l ± 0 ,0 3 m l
O n e - M a r k - P ip e tte 25 m l ± 0 ,0 3 m l ± 0 ,0 3 m l
O n e - M a r k - P ip e tte 50 m l ± 0 ,0 5 m l ± 0 ,0 5 m l
O n e - M a r k - P ip e tte 100 m l ± 0 ,0 8 m l ± 0 ,0 8 m l
( T r a n s f e r p ip e tte )
IS O F D IS 8 3 5 BBR - USP - E
G r a d u a te d P ip e tte 0 ,5 m l ± 0 ,0 0 6 m l ± 0 ,0 1 m l
G r a d u a te d P ip e tte 1 ml ± 0 ,0 0 7 m l ± 0 ,0 1 m l
G r a d u a te d P ip e tte 2 ml ± 0 ,0 1 m l ± 0 ,0 1 m l
G r a d u a te d P ip e tte 5 ml ± 0 ,0 3 m l ± 0 ,0 2 m l
G r a d u a te d P ip e tte 10 m l ± 0 ,0 5 m l ± 0 ,0 3 m l
G r a d u a te d P ip e tte 20 m l ± 0 ,1 m l ± 0 ,0 5 m l
G r a d u a te d P ip e tte 25 m l ± 0 ,1 m l ± 0 ,0 5 m l

IS O 3 8 5 BBR - USP - E
B u re t 2 m l : 0 ,0 1 ± 0 ,0 1 m l ± 0 ,0 1 m l
B u re t 5 m l : 0 ,0 1 ± 0 ,0 1 m l ± 0 ,0 1 m l
B u re t 1 0 m l : 0 ,0 2 ± 0 ,0 2 m l ± 0 ,0 2 m l
B u re t 2 5 m l : 0 ,0 5 ± 0 ,0 3 m l ± 0 ,0 3 m l
B u re t 5 0 m l : 0 ,1 ± 0 ,0 5 m l ± 0 ,0 5 m l

IS O 1 0 4 2 BBR - USP - C / E
V o lu m e tr ic F la s k 5 ml ± 0 ,0 2 5 m l ± 0 ,0 2 m l
V o lu m e tr ic F la s k 10 m l ± 0 ,0 2 5 m l ± 0 ,0 2 m l
V o lu m e tr ic F la s k 20 m l ± 0 ,0 4 m l ± 0 ,0 3 m l
V o lu m e tr ic F la s k 25 m l ± 0 ,0 4 m l ± 0 ,0 3 m l
V o lu m e tr ic F la s k 50 m l ± 0 ,0 6 m l ± 0 ,0 5 m l
V o lu m e tr ic F la s k 100 m l ± 0 ,1 m l ± 0 ,0 8 m l
V o lu m e tr ic F la s k 200 m l ± 0 ,1 5 m l ± 0 ,1 m l
V o lu m e tr ic F la s k 250 m l ± 0 ,1 5 m l ± 0 ,1 2 m l
V o lu m e tr ic F la s k 500 m l ± 0 ,2 5 m l ± 0 ,1 5 m l
V o lu m e tr ic F la s k 1000 m l ± 0 ,4 m l ± 0 ,3 m l
V o lu m e tr ic F la s k 2000 m l ± 0 ,6 m l ± 0 ,5 m l
V o lu m e tr ic F la s k 5000 m l ± 1 ,2 m l ± 1 ,2 5 m l

IS O 4 7 8 8 BBR - USP - E
G r a d u a te d C y lin d e r 5 ml ± 0 ,0 5 m l ± 0 ,0 5 m l
G r a d u a te d C y lin d e r 10 m l ± 0 ,1 m l ± 0 ,0 8 m l
G r a d u a te d C y lin d e r 25 m l ± 0 ,2 5 m l ± 0 ,1 4 m l
G r a d u a te d C y lin d e r 50 m l ± 0 ,5 m l ± 0 ,2 m l
G r a d u a te d C y lin d e r 100 m l ± 0 ,5 m l ± 0 ,3 5 m l
G r a d u a te d C y lin d e r 250 m l ± 1 ml ± 0 ,6 5 m l
G r a d u a te d C y lin d e r 500 m l ± 2 ,5 m l ± 1 ,1 m l
G r a d u a te d C y lin d e r 1000 m l ± 5 ml ± 2 ml

BBR - USP - E These istruments can only be delivered with USP individual certificate.
The engraved serial number additionally carries the sign "USP".
BBR - USP - C / E Volumetric flasks generally can be delivered with USP batch certificate.
"USP" is indicated above the BLAUBRAND® logo on the instrument.
Of course, individual certificates can be issued, too.

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